Lok Sabha Question No. 1113 (UNSTARRED), answered on 2015-12-04
Subject: Study/Clinical Trials of Ayurvedic, Homoeopathic and Unani Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: SHRIKANT EKNATH SHINDE, MANOJ RAJORIA, R. PARTHIPAN, PARASURAMAN K., VINAYAK BHAURAO RAUT, RAHUL RAMESH SHEWALE

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK  SABHA UNSTARRED QUESTION NO.1113 TO BE ANSWERED ON 4 TH DECEMBER, 2015

## STUDY/CLINICAL TRIAL S OF AYURVEDIC, HOMO EOPATHIC AND UNANI MEDICINES

## 1113. DR. SHRIKANT EKNATH SHINDE:

DR. MANOJ RAJORIA:

SHRI R. PARTHIPAN:

SHRI K. PARASURAMAN:

SHRI VINAYAK BHAURAO RAUT:

SHRI RAHUL SHEWALE:

Will the Minister of AYURVEDA,YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state :

- (a) whether the Government has conducted any study/clinical trial to check the authenti Ayurvedic,  Homoeopathic  and  Unani  medicines  in  different  ailments/diseases  includi effectiveness of Aloe vera, Giloy on patients suffering from different tropical diseases such dengue, malaria and some of the viruses causing seasonal influenza;
- (b) if so, the details and the outcome thereof indicating such clinical trials conduc Government during the last three years; and
- (c) the steps taken by the Government to promote research/treatment of AYUSH medicines the country along with the guidelines formulated to oversee such research/clinical trials?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

- (a)& ( b): Research Councils under Government of India have conducted and are conducting clinical studies to evaluate the efficacy of Ayurvedic, Unani and Homoeopathic medicines in various ailments. Central Council for Research in Homoeopathy has undertaken clinical st on Chikungunya and influenza like illness. Council wise list of such studies conducted dur last three years is annexed providing their details and outcomes.  Studies for efficacy ev of Aloe vera and Giloy alone in dengue and malaria are not reported though these medi plants are widely used in accordance with the principles and concepts o f AYUSH systems.

Contd…….

( c): Government has set up Central Research Councils with 80 field units distributed a the  country  for  promoting  scientific  validation  and  efficacy  evaluation  studies  of  Ayu Siddha, Unani and Homoeopathic medicines.  Though t he term 'Clinical Trial' as such is not prescribed in the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder pertaini Ayurvedic,  Siddha,  Unani  and  Homoeopathic  medicines,  yet  Ministry  of  AYUSH  has  tak en steps for facilitating clinical trials in AYUSH, like publication of Good Clin cal Practice (GCP) guidelines, issuing directive for registration of AYUSH clinical trials in Clinical Tria of India, setting up of an Expert Committee to make recommendations for grant of approval to new  clinical  trial  proposals  and  implementation  of  a central  sector  scheme  of  extra - mural research for supporting scientific exploration of AYUSH interventions and remedies in va medical  and  other  R&D  instituti ons.Also,  Rule  158 - B  has  been  inserted  in  the  Drugs  and Cosmetics Rules, 1945 for seeking the proof of effectiveness and safety of certain categ Ayurvedic, Siddha and Unani medicines as a licensing requirement.  Si milarly, prior to licensing of  ne w  homoeopathic  medicines  there  is  a  statutory  requirement of documentary and  other evidence of therapeutic efficacy including the minimum proving carried out with them. Central Council  for  Research  in  Ayurveda  Sciences  (CCRAS)  and  Central  Council  for  Resea rch  in Unani  Medicines(CCRUM)  have  signed  MOUs  with  Indian  Council  of  Medical  Research (ICMR)  for  joint  collaborative  projects  on  Ayurvedic  and  Unani  formulations  relate treatment of Dengue and Tuberculosis respectively.

………

## I. CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES

## a) List of completed clinical research projects during last 3 years

|   S.No. | Clinical Research                                                                                                            | Outcomes                                       |
|---------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
|       1 | Multicentric Open Clinical Trial of Rajahpravarini Dysmennorhea.                                                             | Vati in Research outcomes published in journal |
|       2 | Clinical evaluation of Vyaghri Haritaki in the of Bronchial Asthma                                                           | management Data analysis is under process      |
|       3 | Clinical evaluation of Vyaghri Haritaki in the management of Chronic Bronchitis                                              | Do                                             |
|       4 | Clinical evaluation of Brahmi Ghrita and jyotishmati in the management of Cognitive Deficit                                  | Taila Do                                       |
|       5 | Clinical evaluation of MahaTriphaladya Ghrita management of Allergic Conjunctivitis                                          | in the Do                                      |
|       6 | Clinical evaluation of Maha Triphaladya Ghrita management of Dry Eye Syndrome                                                | in the Do                                      |
|       7 | Clinical evaluation of Vyoshadi Guggulu and Haritaki Churna in the management of Dyslipidemia                                | Do                                             |
|       8 | Clinical evaluation of Saptavimshatika Guggulu and Churna in the management of Type II Diabetes Mellitus                     | Haridra Do                                     |
|       9 | Clinical evaluation of Ashvagandhadyarishta, Jatamamsi Arka and Sarpagandha Vati in the management of Essential Hypertension | Do                                             |
|      10 | Clinical evaluation of Bilvadi Leha in the management Irritable Bowel Syndrome                                               | of Do                                          |
|      11 | Clinical evaluation of Punarnavadi Mandura and Dadimadi Ghrita in the management of Iron Deficien cy Anaemia                 | Do                                             |
|      12 | Clinical evaluation of Ashokarishta, Ashvagandha and Pravala Pishti in the management of Menopausal Syndrome                 | Churna Do                                      |
|      13 | Clinical evaluation of Punarnava Guggulu, Dashmoola Ghrita and Kottamachukadi Taila in the management Osteoarthritis         | of Do                                          |
|      14 | Clinical evaluation of Vyoshadi Guggulu and Churna in the management of Obesity                                              | Haritaki Do                                    |
|      15 | Clinical evaluation of Laksha Guggulu and Mukta Pishti in the management of Osteopenia/Osteoporosis                          | Shukti Do                                      |
|      16 | Clinical evaluation of Simhanaada Guggulu a nd Brihata Saindhavadi Taila in the management of Rheumatoid Arthritis           | Do                                             |
|      17 | Clinical evaluation of Rasayana effect of Ashwagandhadi Lehya in Apparently Healthy Elderly Persons                          | Do                                             |

|   18. | Clinical Evaluation of Nisha Amalaki and Chandraprabha Vati in the management of Type -II Diabetes mellitus (Madhumeha)                                            | Do                |
|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
|    19 | Clinical evaluation of Vajraka Ghrita, Arogyavardini and Dineshavalyadi Taila in the management of (Psoriasis)                                                     | Vati Kitibha Do   |
|    20 | Clinical evaluation of Vatari Guggulu, Rasna Kashaya a nd Brihat Saindhavadi Taila in the management Rheumatoid Arthritis.                                         | Saptaka of Do     |
|    21 | Clinical evaluation of Vatari Guggulu, Maharasnadi and Narayana Taila in the management of Osteoarthritis knee.                                                    | Kvatha Do         |
|    22 | Clinical evaluation of of Ksheerbala Taila Matra , Vatari Guggulu,Maha Rasnadi Kvatha and Narayana taila the management of Osteoarthritis Knee.                    | Basti in Do       |
|    23 | Evaluation of clinical efficacy & Safety of the karma followed by Takradhara & Rasaushadhi Rasayana Chikitsa in Kitibha (Psoriasis).                               | Vamana Do         |
|    24 | A clinical evaluation of efficacy of Pranada gutika and Abhayaristha in the management of Arsha (Haemorrhoids)                                                     | Do                |
|    25 | Evaluation of clinical efficacy and safety of Brahma Apparently healthy elderly persons.                                                                           | Rasayana in Do    |
|    26 | Clinical evaluation of Nisha Katak adi Kashaya and Yashada Bhasma in the management of Type - II Diabetes Mellitus (Madhumeha)                                     | Do                |
|    27 | Clinical evaluation of efficacy of Rajahpravartini Kanchanara guggulu and Varunadi Kashaya in the management of Polycystic Ovarian Syndrome (PCOS): A pi lot study | Vati, Do          |
|    28 | An open label efficacy study of Amrita Guggulu and Pinda in the management of hyperuricemia in Gout (Vatarakta)                                                    | taila patients Do |

## b) Completed Collaborative clinical research projects during last 3 years

|   S.No. | Details of the clinical research                                                                                                                                                             | Outcome                             |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
|       1 | Multicentric double blind randomized controlled clinical trial of coded drug AYUSH- Manas in mental retardation (Manas mandata) in children                                                  | Data analysis is under process.     |
|       2 | Double blind randomized controlled clinical trial of coded drug AYUSH-QOL2C for improvement of Quality of Life in stage III and IV Non Small Cell Lung cancer as an adjuvant to chemotherapy | Technical report under preparation. |

## II. CENTRAL COUNCIL FOR RESEARCH IN UNANI MEDICINE a) Disease in which leads achieved and drugs developed

## b) Disease-wise Unani Pharmacopoeal formulations validated studies

|   S.No | Disease ( 10)                               | Drugs (20)                     |
|--------|---------------------------------------------|--------------------------------|
|      1 | So ul Qiniya (Anaemia)                      | Sharbat e Faulad               |
|      2 | Busoor Jild (Boils and Pustules             | Majoon e Ushba                 |
|      2 | Busoor Jild (Boils and Pustules             | Arq e Murakkab Musaffi Khoon   |
|      3 | Kasrat- e- Ratubat-e-Hamoozi (Hyperacidity) | Habb e Papita,                 |
|      3 | Kasrat- e- Ratubat-e-Hamoozi (Hyperacidity) | JawarishAmla                   |
|      4 | Bawaseer-e-Damiya (Hemorrhoids)             | HabbeRasuat,                   |
|      4 | Bawaseer-e-Damiya (Hemorrhoids)             | Habb-e- Muqil,                 |
|      4 | Bawaseer-e-Damiya (Hemorrhoids)             | Majoon e Muqil and             |
|      4 | Bawaseer-e-Damiya (Hemorrhoids)             | Marham e Saeeda Chob Neem Wala |
|      5 | Surat-e-Inzaal (Premature ejaculation)      | Safoof e Mughalliz Mani,       |
|      5 | Surat-e-Inzaal (Premature ejaculation)      | Majoon Arad Khurma and         |
|      5 | Surat-e-Inzaal (Premature ejaculation)      | Habb e Ikseer                  |
|      6 | Waja ul Mafasil (Rheumatoid Arthritis)      | MajoonSuranjan,                |
|      6 | Waja ul Mafasil (Rheumatoid Arthritis)      | Safoof e Suranjan,             |
|      6 | Waja ul Mafasil (Rheumatoid Arthritis)      | Raughan e Suranjan             |
|      7 | Zaheer                                      | Safoof e Zaheer                |

|   8. | Nisyan (Amnesia)            | MajoonNisyan                       |
|------|-----------------------------|------------------------------------|
|    9 | Waja-ul-Mafasil(Joint Pain) | Raughan e Suranjan Habb e Suranjan |
|   10 | Nazla-e- Hār (Common Cold)  | Habb-e- Shifa                      |

## c) Ongoing Pharmacopoeal Validation studies

| S.No                                                               | Diseases                                                           | Drugs                                                              |
|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Clinical validation of Pharmacopoeal Drugs (24 diseases, 47 drugs) | Clinical validation of Pharmacopoeal Drugs (24 diseases, 47 drugs) | Clinical validation of Pharmacopoeal Drugs (24 diseases, 47 drugs) |
| 1.                                                                 | Zof-e-Masana                                                       | MajoonKundur,                                                      |
| 1.                                                                 | Zof-e-Masana                                                       | JawarishZarooni,                                                   |
| 1.                                                                 | Zof-e-Masana                                                       | Arq e Badiyan,                                                     |
| 1.                                                                 | Zof-e-Masana                                                       | Majoon Filasafa,                                                   |
| 1.                                                                 | Zof-e-Masana                                                       | Majoon Masikul Baul                                                |
| 2.                                                                 | Warm e Kabid (Hepatitis)                                           | Arq e Kasni,                                                       |
| 2.                                                                 | Warm e Kabid (Hepatitis)                                           | Arq e Mako,                                                        |
| 2.                                                                 | Warm e Kabid (Hepatitis)                                           | Majoon-e-Dabeed-ul-Ward                                            |
| 2.                                                                 | Warm e Kabid (Hepatitis)                                           | Sharbat e Bazoori Motadil                                          |
| 3.                                                                 | Sailan-ur-Reham (Leucorrhoea)                                      | Kushta Khubsul Hadeed                                              |
| 3.                                                                 | Sailan-ur-Reham (Leucorrhoea)                                      | Habb e Marwareed,                                                  |
| 3.                                                                 | Sailan-ur-Reham (Leucorrhoea)                                      | Majoon Suparipak                                                   |
| 3.                                                                 | Sailan-ur-Reham (Leucorrhoea)                                      | Sufoof-e-Sailan                                                    |
| 3.                                                                 | Sailan-ur-Reham (Leucorrhoea)                                      | Majoon Muqawwi e Reham                                             |
| 4.                                                                 | Deedan e Ama (Helminthiasis)                                       | Qurs e Deedan                                                      |
| 5.                                                                 | Niqras (Gout)                                                      | Majoon e Suranjan                                                  |
| 5.                                                                 | Niqras (Gout)                                                      | Habb e Azaraqi                                                     |
| 6.                                                                 | Khafqan (Palpitation)                                              | Dawaul Misk Motadil Sada                                           |
| 6.                                                                 | Khafqan (Palpitation)                                              | Jawarish-e-Shahi                                                   |
| 6.                                                                 | Khafqan (Palpitation)                                              | Khamira Sandal Sada                                                |
| 7.                                                                 | Ziabetus (Diabetes Mellitus Type -II)                              | Qurs e Ziabetus Khas                                               |
| 8.                                                                 | Sual e Yaabis (Dry Cough)                                          | Sharbat Ejaz                                                       |
| 8.                                                                 | Sual e Yaabis (Dry Cough)                                          | Sharbat e aSadar                                                   |
| 9.                                                                 | Su e Hazm (Dypepsia)                                               | Jawarish Kamooni                                                   |
| 9.                                                                 | Su e Hazm (Dypepsia)                                               | Arq Badiyan                                                        |
| 10.                                                                | Jarab (Scabies)                                                    | Itrifal Shahtara                                                   |
| 10.                                                                | Jarab (Scabies)                                                    | Marham e Kharish                                                   |
| 10.                                                                | Jarab (Scabies)                                                    | Aab e Neem                                                         |
| 10.                                                                | Jarab (Scabies)                                                    | Majoon-e-Chobchini                                                 |
| 11.                                                                | Hisatul Kulyah (Nephrolithiasis)                                   | Safoof Hajrul Yahood                                               |
| 11.                                                                | Hisatul Kulyah (Nephrolithiasis)                                   | Safoof Pathar Phori                                                |
| 11.                                                                | Hisatul Kulyah (Nephrolithiasis)                                   | Sharbat e Bazoori motadil                                          |
| 12.                                                                | Zof e Ishtiha (Anorexia)                                           | Jawarish Ood Shireen                                               |
| 12.                                                                | Zof e Ishtiha (Anorexia)                                           | Hab e Hilteet                                                      |
| 12.                                                                | Zof e Ishtiha (Anorexia)                                           | Hab e Tursh Mushtahi                                               |

| 13.                                                     | 13.                                                     | Zaheer                                                  | Sharbat e Belgiri                                       |
|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| 14.                                                     | 14.                                                     | Sool Qiniya (Anaemia)                                   | Damavi                                                  |
| 15.                                                     | 15.                                                     | Nisyan (Amnesia)                                        | Majoon Muqawwi e Dimagh                                 |
| 16.                                                     | 16.                                                     | BusoorJild (Macules and Pustules)                       | Itrifal shahtara Sharbat Unnab                          |
| 17.                                                     | 17.                                                     | Waja-ul-Mafasil(Rheumatoid Arthritis)                   | Majoon Jograaj Goggul Habb e Asgandh Raughan Malkangani |
| 18.                                                     | 18.                                                     | Kalaf (Melasma)                                         | Zimaad e Baras                                          |
| 19. 20. 21.                                             | 19. 20. 21.                                             | Nazla Muzmin                                            | Itrifal Ustukhudus                                      |
|                                                         |                                                         | Zof-e-Dimagh                                            | Khamira-e-Gaozaban Sada                                 |
|                                                         |                                                         | Kasrat-e-Tams                                           | Sufoof-e-Habis-ud-Dam                                   |
| 22.                                                     | 22.                                                     | Khushunat-e-Halq                                        | Lauq Badam                                              |
| 23.                                                     | 23.                                                     | Zeeq un Nafas                                           | Lauq e Katan                                            |
| Validation of Fast Acting Drugs ( 8 Diseases, 9 Drugs ) | Validation of Fast Acting Drugs ( 8 Diseases, 9 Drugs ) | Validation of Fast Acting Drugs ( 8 Diseases, 9 Drugs ) | Validation of Fast Acting Drugs ( 8 Diseases, 9 Drugs ) |
| 1.                                                      | Sual Ratab (Productive Cough)                           | Sual Ratab (Productive Cough)                           | Sharbat Zufa Murakkab Habb e Surfa                      |
| 2.                                                      | Qula (Stomatitis)                                       | Qula (Stomatitis)                                       | Zaroor e Kath                                           |
| 3.                                                      | Sudā' (Headache)                                        | Sudā' (Headache)                                        | Arq e Ajeeb                                             |
| 4.                                                      | Wajaul Asnan(Toothache)                                 | Wajaul Asnan(Toothache)                                 | Raughan Ikseer                                          |
| 5.                                                      | Shara (Urticaria)                                       | Shara (Urticaria)                                       | Qurs Asfar                                              |
| 6.                                                      | Waram e Halaq (Pharyngitis)                             | Waram e Halaq (Pharyngitis)                             | Sharbat Toot Siyah                                      |
| 7.                                                      | Sahar (Insomnia)                                        | Sahar (Insomnia)                                        | Raughan-e-Luboob e- Saba                                |
| 8.                                                      | Nazla                                                   | Nazla                                                   | Laooq-e-Sapistan                                        |

## III. CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY

Outcomes of research projects undertaken by Central Council for Research in Homoeopathy during the last three years.

| Sl.No.   | condition               | Study design        | Outcome                                                                                                                                                                                                           | Publication                                                                                                                                    |
|----------|-------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
|          | Clinical Research       |                     |                                                                                                                                                                                                                   | A                                                                                                                                              |
| 1.       | Diabetic polyneuropathy | Observational study | A total of 247 patients suffering from diabetic polyneuropathy were given individualized homoeopathic medicine for period of 12 months and results reflected significant improvement in their symptoms and signs. | prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy. Homeopathy. 2013; Apr; 102(2) :130-8. |

|   Sl.No. | condition                              | Study design                                                   | Outcome                                                                                                                                                                                                                                                                                                                                  | Publication                                                                                                                                                                                 |
|----------|----------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        2 | Haemorrhoids                           | multicentric randomized single-blind placebo- controlled trial | the medicines most frequently prescribed. After 90 days of treatment, a significant reduction (P = 0.0001) was found in the median area under the curve for symptoms of haemorrhoids and Quality of Life-favouring homoeopathy. Most frequently prescribed medicines were: Nuv vomica, Phosphorus, Sulphur. 1.                           | Effect of homoeopathic LM potencies in acute attacks of haemorrhoidal disease: A multicentric randomized single-blind placebo- controlled trial. Indian J Res Homoeopathy 2013;7(2):72- 80. |
|        3 | Depressive episode                     | Observational study                                            | A total of 83 patients completed the follow-up, treated for depressive episodes with homoeopathic medicines showed statistically significant reduction in the mean scores (P = 0.0001, P < 0.05). The most frequently used medicines were: Natrum muriaticum, Arsenicum album, Pulsatilla nigricans, Lycopodium clavatum and Phosphorus. | Homoeopathic management in depressive episodes: A prospective, unicentric, non- comparative, open-label observational study. Indian Journal of Research in Homœopathy 2013;7(3): 116- 125   |
|        4 | Attention deficit hyperactive disorder | Randomized placebo controlled pilot trial                      | A total of 54 patients (homoeopathy = 27, placebo = 27) were analysed under modified intention to treat (ITT). All patients in homoeopathy group showed better outcome in ( P = 0.0001) favouring homoeopathy group (p=0.0001). Frequently used medicines were calcarea carb., Lycopodium, Phosphorus .                                  | Homoeopathic management of attention deficit hyperactivity disorder: A randomised placebo controlled pilot trial. Indian J Res Homoeopathy 2013;7(4):158-67.                                |
|        5 | Benign Prostatic Hyperplasia           | Observational study                                            | Homoeopathic intervention to patients suffering from benign prostatic hyperplasia for a period of 12 months showed improvement in symptoms There was a statistically significant reduction in American Urological                                                                                                                        | Homoeopathic medicines in the management of benign prostatic hyperplasia: A multicentric prospective observational study . Indian Journal of Research in Homoeopathy 2012; 6 ( 3): 16-25    |

| Sl.No.   | condition            | Study design                                | Outcome                                                                                                                                                                                                                                                                                                                                                                             | Publication                                                                                                                                                                                                                                      |
|----------|----------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|          |                      |                                             | Association Symptom Index, p= 0.0001). The medicines found to be most useful in this study are: Thuja, Sulphur, Pulsatilla, Lycopodium . There was a mean reduction of 2.3 ml in prostate volume, which was significant statistically (p=0.005).                                                                                                                                    |                                                                                                                                                                                                                                                  |
| 6.       | Chronic sinusitis    | Observational study                         | Statistically significant reduction after treatment (p=0.0001) was found in chronic sinusitis assessment score developed by CCRH. Silicea, Lycopodium, Phosphorus and Kali iodata were found to be most useful medicines among pre-defined trial medicines.                                                                                                                         | Homeopathy in Chronic Sinusitis: A Prospective Multi- centric Observational Study. Homeopathy 2012; 101(2): 84-91.                                                                                                                               |
| 7.       | Acute otitis media   | Randomized controlled trial                 | Individualized Homœopathy is as effective as conventional treatment (analgesics, antipyretics and anti- inflammatory drugs) in acute otitis media. Symptomatic improvement was quicker in the Homœopathy group. Antibiotics were not required for patients in Homœopathy group whereas 97.5% patients in conventional group required an antibiotic.                                 | Randomized controlled pilot study to compare Homœopathy and conventional therapy in acute otitis media. Homeopathy 2012; 101(1): 5-12.                                                                                                           |
| 8.       | Cervical spondylosis | Prospective randomized clinical pilot study | Patients suffering from cervical spondylosis treated with homoeopathic medicine showed significant reduction in pain under LM group [p= 0.007]. Overall quality of life of the patients after homeopathic medication showed significant improvement. Most frequently used homeopathic medicines in both the groups are: Lyc., Sulp. , Bry. Phos.,Calc. ,Nux- v., Rhus- t.,Nat-m. 1. | Homoeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis: A multicenter prospective randomized exploratory clinical study. Indian Journal of Research in Homoeopathy 2012; 6(4): 16- 23. |

| Sl.No.   | condition                      | Study design                                     | Outcome                                                                                                                                                                                                                                                                                                                                                                                                                             | Publication                                                                                                                                                                                                                                |
|----------|--------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9. 1     | Chikungunya                    | Randomized double blind placebo controlled trial | Identified homoeopathic Bryonia alba 30 C for the epidemic resulted in producing 19.76% prevention as compared to placebo in prevention of chikungunya.                                                                                                                                                                                                                                                                             | Homoeopathic Genus Epidemicus 'Bryonia alba' as a prophylactic during an outbreak of Chikungunya in India: A cluster -randomised, double -blind, placebo- controlled trial. Indian Journal of Research in Homoeopathy 2014; 8(3):: 160-165 |
| 10.      | Influenza like illness         | Randomized placebo controlled trial              | In this study, 447 cases were enrolled in three groups: LM group (n=152), C group (n=147) and Placebo (n=148) cases. There was a significant improvement in fever, headache, myalgia, sore throat, fatigue, nasal complaints, sweat and Cough in patients suffering from ILI. The medicines which were commonly prescribed were: Ars. alb., Bry. alb., Rhus tox , Bell., Nux vom., Sepia, Phos., Gels., Sulph., Nat. mur. and Acon. | Effect of individualized homoeopathic treatment in influenza like illness: A multicenter, single blind, randomized, placebo controlled study. Indian J Res Homoeopathy 2013;7:22-30.                                                       |
| 11.      | Influenza like illness         | Data collection survey                           | 23 homeopathic physicians contributed to data collection. The most frequently prescribed being Arsenicum album (n = 265; 23.5%). For a total of 99 FU appointments with valid SF symptoms, Arsenicum album was prescribed most frequently overall (n = 28; 28.0%).                                                                                                                                                                  | Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in India.Homeopathy2013 Jul;102(3):187-92.                                                                                         |
| 12.      | Acute Alcohol withdrawal (AAW) | Observational study                              | Individualised Homoeopathy was given to 112 patients reporting with AAW. The clinical assessment done for 05 days showed significant decrease in mean scores and increase in quality of life score ( P < 0.001). The most common remedies used were Arsenicum album, Lycopodium clavatum, Belladonna, Nux                                                                                                                           | Managing acute alcohol withdrawal with Homoeopathy: A prospective, observational, multicentre exploratory study. Indian Journal of Research in Homœopathy 2014;8(4):224-230                                                                |

| Sl.No.   | condition                   | Study design                | Outcome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Publication                                                                                                                                                                                                 |
|----------|-----------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|          |                             |                             | vomica and Pulsatilla .                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                             |
| 13.      | Acute encephalitis syndrome |                             | 151 children (121 in IMP + H and 30 in only IMP) diagnosed with AES were enrolled. The results showed 12 (9.9%) death out of 121 children administered IMP + H whereas it was 13 (43%) out of 30 children on IMP alone. The most useful medicines are Belladonna, Stramonium, Arsenicum album, Helleborus, Bryonia alba, Sulphur, and Cuprum metallicum.                                                                                                                                             | Evaluation of homoeopathic medicines as add-on to institutional management protocol in Acute Encephalitis Syndrome: An exploratory observational comparative study. Indian J Res Homoeopathy 2015;9:34- 41. |
| 14.      | Vitiligo                    | Observational study         | Homoeopathic treatment was found to be useful in relieving vitiligo in varying degrees in 126 patients, out of which 4 (2.94%) cases showed marked improvement, 15 (11.03%) cases showed moderate improvement, 77 (56.62%) cases showed mild improvement, and 30 patients did not improvement significantly. Ten homoeopathic medicines were found useful in the study of which Sulphur, Arsenicum album, Phosphorus, and Lycopodium clavatum were the most commonly indicated and useful medicines. | A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo. Indian J Res Homoeopathy 2015;9:167- 75.                                                                       |
| 15.      | Lymphatic filariasis        | Randomized controlled trial | A total of 112 patients (homoeopathy -55 and allopathy-57 ) analysed under the treatment group of 11 days out of which 107 patients were analysed on a                                                                                                                                                                                                                                                                                                                                               | Submitted for publication.                                                                                                                                                                                  |

| Sl.No.   | condition                   | Study design                | Outcome                                                                                                                                                                                                                                                                                                                                                                                                                                       | Publication       |
|----------|-----------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
|          |                             |                             | six months treatment scale. All patients in homoeopathy group showed a significant improvement in the intensity and frequency of ADL attacks. The quality of life of the patients were also improved. Medicines like Apis mellifica, Rhustoxiconderon, Pulsatilla, Arsenic album, Bryonia alba and Hepar sulph. were most useful in the acute attacks whereas Lycopodium, Natrum mur. ,Sulphur, Pulsatilla and Calcarea carb were prescribed. |                   |
| 16.      | Menopause                   | Randomized controlled trial | A total of 471 cases were screened out of which 88 cases were enrolled according to Inclusion criteria. Out of 88 cases 07 cases are dropped out.                                                                                                                                                                                                                                                                                             | Under analysis    |
| 17.      | Chronic rhinosinusitis      | Randomized controlled trial | A total of 317 cases were screened out of which 121 cases were enrolled according to Inclusion criteria. Study showed significant improvement in global assessment by patient and physician.                                                                                                                                                                                                                                                  | Under analysis    |
| 18.      | Polycystic ovarian syndrome | Randomized controlled trial | A total of 120 cases were screened out of which 60 cases were enrolled according to Inclusion criteria. Study showed significant improvement primary and secondary outcomes.                                                                                                                                                                                                                                                                  | Under analysis    |
| 19.      | Alcohol dependence          | Randomized controlled trial | As per ITT analysis, 32(80%) patients in IH and 15(37.5%) in the SA responded to treatment: absolute difference 42.5%, p= 0.0002. The medicines frequently prescribed were Sulphur,                                                                                                                                                                                                                                                           | Under publication |

|   Sl.No. | condition                       | Study design        | Outcome                                                                                                                                                                                                                                                                                                                                                                                           | Publication                      |
|----------|---------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
|       20 | Schizophrenia                   | Observational study | Out of 171 enrolled patients 105 completed 12 month follow-up and 66 visited for varied time period. Significant difference (p = 0.0001, p < 0.05) in the mean scores of BPRS, using paired t-test was observed at end of the study. Sulphur, Lycopodium, Natrum mur, Pulsatilla nig. and Phosphorus were found to be the most effective medicines in treating schizophrenic patients.            | Submitted for publication.       |
|       21 | Gatroesophag eal reflex disease | Observational study | 78 patients were screened & 36 patients were enrolled. Data was analysed and the outcome of the study shows that there is improvement in GERD symptom score. The Quality of life also showed improvement in all the patients. The medicines found effective in study were Lycopodium , Nux vomica, Phosphorus, Cinchona Officinalis, Pulsatilla nigricum, Arsenicum album, Natrum Muriaticum etc. | Manuscript is under preparation. |
|       22 | Osteoarthritis                  | Observational study | Out of 74 patients screened in the OPDs, 47 (63.51%) met the eligibility criteria and were enrolled in the study. All were given to individualized homoeopathic medicine for 8 days. 12 (25.53%) patients were lost to follow-up, and 35 (74.47%) completed the study.                                                                                                                            | Under publication                |

| Sl.No.   | condition                                 | Study design                | Outcome                                                                                                                                                                                                                                                                                                                                                                                                          | Publication    |
|----------|-------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
|          |                                           |                             | Statistically significant reduction in pain, stiffness, loss of physical function measured on VAS (mm) was seen. Assessments made on OARSI-OMERACT intermittent or constant pain measure score compared at baseline and after 7 days also showed significant improvement Rhus toxicodendron, Bryonia alba, Causticum, and Pulsatilla nigricans, Arnica montana, Calcarea carbonica, and Sulphur were prescribed. |                |
| 23.      | Benign Prostatic Hyperplasia              | Randomized controlled trial | A total of 474 cases were screened out of which 250 cases were enrolled according to Inclusion criteria. The results are under analysis.                                                                                                                                                                                                                                                                         | Under analysis |
| 24.      | Diabetic distal symmetric polyneuropath y |                             | A total of 474 cases were screened out of which 250 cases were enrolled according to Inclusion criteria. The results are under analysis. 487 patients have been screened and 85 patients were enrolled in the study. The results are under analysis.                                                                                                                                                             | Under analysis |
| 25.      | Leptospirosis                             | Randomized controlled trial | A total of 213 patients were screened and 160 were excluded. 53 patients were enrolled wherein individualized Homoeopathic medicine was being administered as an adjuvant to standard care (Homoeopathy + standard care: 26; Placebo + standard care: 27). All the patients in the trial were improved. There was no death reported.                                                                             | Under analysis |

| Sl.No.   | condition                 | Study design                | Outcome                                                                                                                                                                                                                                          | Publication       |
|----------|---------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 26.      | Cervical spondylosis      | Randomized controlled trial | Out of 498 screened cases, 134 cases were enrolled in the study comprising of 66 cases in Homoeopathy group and 68 cases in Placebo Group. Medicines which were most commonly used were; Rhus tox., Calcarea carb, Kalmia and Paris Quadrifolia. | Under analysis    |
|          | Clinical verification     | Observational study         | During the last three years 23 drugs were verified clinically on various disease conditions.                                                                                                                                                     |                   |
| 27.      | Agave americana           | Observational study         | Dermatitis, Stomatitis, Vertigo, Headache, Tonsillitis, Colic, Spondylosis.                                                                                                                                                                      | Under publication |
| 28.      | Andrographis paniculata   | Observational study         | Allergic Rhinitis, Gastritis, Frozen shoulder, Metorrhagia, Pharyngitis, Headache, Piles, Conjunctivitis.                                                                                                                                        | Under publication |
| 29.      | Argemone mexicana         | Observational study         | Fever, Pharyngitis, Alopecia, Allergic Dermatitis, Sinusitis, Gastritis, Insomnia, Urticaria, Conjunctivitis , Constipation, Herpetic eruptions, Eczema, Vertigo .                                                                               | Under publication |
| 30.      | Bacopa monniere           | Observational study         | Conjunctivitis, Gastritis, Urticaria, URTI, Headaches, Dysmenorrhoea, Dermatitis, Anal fissure.                                                                                                                                                  | Under publication |
| 31.      | Chelone glabra            | Observational study         | Worm infection, Sinusitis, Constipation, Cervical spondylosis, Rhinitis, Gastritis, Headache, Torticollis .                                                                                                                                      | Under compilation |
| 32.      | Clerodendron infortunatum | Observational study         | Observational study Ear block, Constipation, Worm infection, Gastritis, Diarrhoea, Headache, Insomnia, Dyspepsia .                                                                                                                               | Ongoing           |
| 33.      | Coleus aromaticus         | Observational study         | Conjunctivitis, Haemorrhoids, Dysentery , Constipation , Dysmenorrhoea, Gastritis, Cough, Eye Infection, Urticaria, UTI, IBS                                                                                                                     | Under compilation |

|   Sl.No. | condition              | Study design        | Outcome                                                                                                                                                     | Publication       |
|----------|------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
|       34 | Cornus circinata       | Observational study | Gastritis, Headache, Dysentery, Abdominal colic, Anorexia, Tonsilitis Fever, Rhinitis, Epistaxis, Myalgia                                                   | Under compilation |
|       35 | Cuprum oxydatum nigrum | Observational study | Dermatitis, Urticaria, Roundworm infection, Eczema                                                                                                          | Under compilation |
|       36 | Ficus religiosa        | Observational study | Constipation, Gastritis, Bleeding piles, Leucorrhoea, Headache, Migraine, Dyspepsia, Vertigo, URTI, Haemorrhoids, Apthous ulcer                             | Under publication |
|       37 | Formic acid            | Observational study | Arthritis, Gout, Polyps, Nephritis, Spermatorrhoea                                                                                                          | Under publication |
|       38 | Hydrocotyle asiatica   | Observational study | Constipation, Leucorrhoea, Acute rhinitis, Stomatitis ,Gout, Cough, Arthritis , Chronic Eczema, Pharyngitis, Indigestion, Vertigo, Dysuria, Abdominal colic | Under publication |
|       39 | Juglans regia          | Observational study | Acne, Bodyache, Fever, Insomnia, Eczema , Melasma, Coryza                                                                                                   | Under publication |
|       40 | Liatris spicata        | Observational study | Dysmenorrhoea, Diarrhoea, Ulcers, PID, Headache, Flatulency, Gastritis, Leucorrhoea                                                                         | Under publication |
|       41 | Mimosa humalis         | Observational study | Constipation, Dermatitis, Coryza, Arthritis, Backache, Rheumatic pain, Urethritis, Neuritis, UTI                                                            | Under publication |
|       42 | Ocimum sanctum         | Observational study | Cough, Urticaria, Aphthae, Dyspepsia, Acne, Leucorrhoea, Alopecia, Fever                                                                                    | Under publication |
|       43 | Paraffin               | Observational study | Constipation, Leucorrhoea, Menorrhagia, Fever, Indigestion, Bodyache, Vertigo, Gastritis, Conjunctivitis                                                    | Under compilation |

|   Sl.No. | condition            | Study design        | Outcome                                                                                                                                                                                  | Publication       |
|----------|----------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
|       44 | Pothos foetidus      | Observational study | Stomatitis , , Constipation, Cough, Urticaria, Fever, Headache, Asthma, UTI, Psoriasis, Acne, Nasopharyngitis, Pharyngitis, Dermatitis, Gastritis, Allergic rhinitis                     | Under compilation |
|       45 | Senega               | Observational study | Dyspnoea, Allergies, Arthritis, Fever, URTI, Coryza, Allergic bronchitis, Migraine, Gastritis, Bronchitis                                                                                | Under compilation |
|       46 | Skookum chuck        | Observational study | Acid Peptic Disorder, Dermatitis, Dysmenorrhoea, Dyspepsia, Gastritis , Vertigo, Rheumatic pain, Fibroedema, Eczema, Urticaria, Allergies                                                | Under publication |
|       47 | Tinospora cordifolia | Observational study | Gastritis, Dyspepsia, Urethritis, Hyperacidity, Anorexia, Chronic amoebiasis, UTI, Fever                                                                                                 | Under publication |
|       48 | Thymol               | Observational study | Rheumatic pain, Sinusitis, Headache, Fever, Rhinitis, Diarrhoea, Vertigo,Leg cramps                                                                                                      | Under compilation |
|       49 | Thyroidinum          | Observational study | Dysmenorrhoea, Oligomenorrhoea, Amenorrhoea, Obesity, PCOD , Rheumatic pain, Arthritis, Vertigo, Headache, Gastritis, Sciatica, Piles, Backache, Goitre, Hyperthyroidism, Hypothyroidism | Under compilation |