Lok Sabha Question No. 67 (STARRED), answered on 2021-02-05
Subject: Research in Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Sanjeev Kumar Singari

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

## LOK SABHA STARRED QUESTION NO. 67 TO BE ANSWERED ON 5 TH FEBRUARY, 2021 RESEARCH IN AYURVEDI C MEDICINES

## *67. DR. SANJEEV KUM AR SINGARI:

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

- (a) whether Government has framed any guidelines for research/clinical tri Ayurvedic  medicines  following  the  rules/protocols  set  by  Orga nization  for Economic Co- operation and Development (OECD), Committee for Purpose of Control and Supervision of Experiments on Animals (CPCSEA) and Institutional Ethics Committee;
- (b) whether mandatory registration in Clinical Trials Registry of India i being followed;
- (c) if the replies to parts (a) and (b) above be in negative, the steps f regulate clinical trials of Ayurvedic drugs in the country;
- (d) whether Government has mandated evidence based trials of Ayurvedic dru prior to their introduction into the market;
- (e)  if  so,  the  details  thereof  including  the  various  trials  that  were during the last six years; and
- (f) if not, the reasons therefor including the steps taken to ensure the efficacy of Ayurvedic rugs?

ANSWER THE MINISTER OF STATE(IC) OF THE MINISTRY OF YOUTH AFFAIRS AND SPORTS AND ADDITIONAL CHARGE OF MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

(SHRI KIREN RIJIJU)

(a) & (f ):  A statement i s laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 67 * FOR 5 TH FEBRUARY, 2021

a) Yes,  Sir.  The  Ministry  of  AYUSH  has  framed Good  Clinical  Practice guidelines  (GCP) for  clinical  trials  in  Ayurveda,  Siddha  and  Unani  (ASU) medicine  in  March  2013  with  a  wide  consultative  process  on  the  basis Central Drugs Standard Control Organization's (CDSCO) publication on 'GCP Guidelines for Clinical Trials on Pharmaceutical Produ cts (2001) and imbibes the  inputs  received  form  Indian  Council  of  Medical  Research  (ICMR) CDSCO,  Central  Councils  for  Research  in  ASU  systems,  experts  from Research  Institutions,  Teaching  Institutions,  State  Regulatory  Bodies representatives from ASU drugs manufacturing industries. As per the rule 1.1 of GCP Guidelines, it is mandatory to have Ethics Committee comprising of medical / scientific and nonmedical / non - scientific members.

- b) Yes, Sir.
- c) Does not arise.

d) As per rule 158 (B) of the Drugs & Cosmetics Act, 1940, the Ayurvedic formulations/ medicines specified in section 3(a) of Drugs & Cosmetics 1940  require  proof  of  effectiveness  to  be  used  for  new  indication;  an Ayurvedic formulations/ medicines specified in section 3(h) of the Act .

e) The clinical trials conducted during the last six years are in the Bronchial Asthma (Tamaka Swasa) , Essential Hypertension, Anxiety Neurosis, Cervical Spondylosis, Urolithiasis, Uterine Fibroid, Obe Computer Vision Syndrome, Menopausal syn drome, Sciatica, Allergic Conjunctivitis,  Influenza  like  Illness,  Fissure  in  Ano,  Anorectal  F Allergic Rhinitis, Primary Dysmenorrheoa, leucorrhoea , Malabsorption Syndrome, Dysfunctional Uterine Bleeding , Age Related Macular Degeneration Symptoms ,H yperacidity/Non ulcer dyspepsia ,Eczema, Mental retardation (Manasamandata) in children, Local Non - Metastatic Breast Cancer, Dengue Fever ,Type 2 Diabetes Mellitus, high grade serous epithelial ovari cancer,  Ante - Natal  care , chronic  Filarial  Lymphoedena, Prevention  and Control  of  Cancer,  Diabetes,  Cardiovascular  diseases  &  Stroke,  COVID - 19 etc. The clinical safety and efficacy of around 92 classical formulation disease conditions has been generated on the basis of preclinical and c safety studies as per the guidelines. The details are at annexure - I.

- f) Does not arise.

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## List of Clinical Research Projects conducted during last 6 years (2014 - 15 to 2019- 20)

## Intra Mural Research Projects

## Completed

1. Clinical Evaluation of Vatari Guggulu, Rasna Saptaka Kashaya and Brih Saindhavadi Taila in the Management of Rheum atoid Arthritis
2. Clinical evaluation of Vatari guggulu, Maharasnadi kwatha and Narayan taila in the management of Osteoarthritis knee.

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3. Clinical Evaluation of Ksheerbala Taila Matra Basti, Combination of Vatari Guggulu, Maharasnadi Kwatha and Na rayan Taila in the Management of Osteoarthritis Knee
4. A  Clinical  Evaluation  of  Efficacy  of  Classical  Ayurvedic  Herbo  Miner Formulations in the Management of Arsha (Hemorrhoids)
5. Evaluation  of  Clinical  efficacy  and  safety  of  Brahma  Rasayana apparently healthy elderly persons
6. Clinical  evaluation  of  the  efficacy  of  Rajahpravartini  vati,  Kanc guggulu  and  Varunadi  kashaya  in  the  management  of  Polycystic  Ovary Syndrome (PCOS): A pilot study
7. An  open  label  efficacy  study  of  Amrita  Guggulu  and  Pinda  Taila in  the management of hyperuricemia in Gout (Vatarakta) patients.
8. Clinical  Evaluation  of  Nisha  Amalaki  and  Chandraprabha  Vati  in  th management of Type II Diabetes Mellitus (Madhumeha)
9. Clinical Evaluation of Vajraka Ghritam, Arogyavardhini Dineshav alyadi taila in the Management of Kitibha (Psoriasis)

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10. Clinical  Evaluation  of  Brahma  Rasayana  in  the  Management of  'Manasa Mandata (Mental Retardation)' -an Open Clinical Trial.
11. Evaluation of clinical efficacy and safety of the Vamana Karma followed Takradhara and Rasaoushadhi Rasayana chikitsa in Kitibha (Psoriasis)
12. Clinical Evaluation of Nisha Katakadi Kashaya and Yashada Bhasma in th Management of Type II Diabetes Mellitus(Madhumeha)
13. Clinical  evaluation  of  Vasavleha  in  the  management  of  Stable  Chron Bronchitis
14. Clinical Evaluation of Yogaraj Guggulu, Gandharvahasta Dhanwantara Taila in the management of Osteoarthritis knee

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15. Clinical Evaluation of Kutajarishta In The Management of  Irritable Bo Syndrome (IBS)
16. Clinical  evaluation  of  Sarasvat a  Ghrita  in  the  management  of  Cognitive Deficit
17. Clinical  evaluation  of  a  Comprehensive  Ayurvedic  Intervention  in  t management of Manodwega (Generalized Anxiety Disorder)
18. Clinical  evaluation  of  Vatari  Guggulu,  Hingvastak  Churna  and  Brih Saindhavadya Tai la in the management of Rheumatoid Arthritis
19. Clinical  Evaluation  Of  Ashwagandha  Churna  and  Pravala  Pishti  in  th Management of Osteopenia / Osteoporosis
20. Clinical  evaluation  of  Navayasa  Chrnua  in  the  management  of  Iro Deficiency Anaemia
21. Clinical evaluatio n of Kanakasava and Trivrita Churna in the management of Bronchial Asthma (Tamaka Swasa)
22. Clinical trial to study the Effect of Chyavanprasha on Aging in Appare Healthy Elderly Subjects
23. Clinical  evaluation  of  Kushmandaka  Rasayana  in  the  management  of Ch ronic Bronchitis (Kaphaja Kasa)
24. Clinical  evaluation  of  Gokshuradi  Guggulu  and  Guduchi  churna  in  th management of Madhumeha (Type II Diabetes Mellitus)
25. Clinical  evaluation  of  efficacy  of  Mahatriphaladi  ghritam  and  Anu  t nasyam in the management of Comp uter Vision Syndrome
26. Clinical efficacy and safety of Brihat Gangadhara Churna management of Irritable Bowel Syndrome.

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27. Clinical  evaluation  of  Parthadyarishtha  (Arjunaristha)  and  Sarpagan Vati in the management of Essential Hypertension (Uccha Rakt achaap)
28. Clinical  evaluation  of  Rudraksha  Churna  in  the  management  of  Essenti Hypertension (Uccha Raktachaapa)
29. Clinical  evaluation  of  Vyoshadi  Guggulu  and  Panchasama  Churna  in Amavata (Rheumatoid Arthritis)
30. Clinical Evaluation of the Efficacy and Safety o f Mamajjaka Ghanavati in Madhumeha (Type 2- Diabetes)
31. Clinical  Evaluation of Shirodhara with Amalaki Kwath in the Patients Anxiety Neurosis
32. Comparative  Observation  on  changes  in  Serum  Lipid  Profile  in  patien undergoing Snehana with pure Ghee in one group and Mahatiktak ghrita i other group
33. Effect of Sankara Sweda with Kolakulatthadi Churna heated in Dhanyamla Simhanada Guggulu with  Rasna S ptak Kashaya in Rheumatoid Arthritis wrt pain and stiffness
34. Evaluation  of  the  Effect  of    Upanaha  treatment  with  Vachadi  upanah churna in Osteoarthritis (OA Knee) wrt pain and stiffness of joints (RF
35. Evaluation of the effect of Jambeera Pinda Sweda in Cervical Spondylosis w.r.t. Clinical Symptomatology
36. Evaluation of changes in serum electrolyte level (na, k etc.) after V karma with Erandataila.
37. Clinical evaluation of efficacy of Panchtiktaguggulu Ghrita Brihanmarichadya Taila in the managem ent of Psoriasis w. s. r. to Pathya -apathya

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38. Clinical evaluation of Goksura churna and Sveta parpati in the Manageme of Mutrasmari (Urolithiasis)
39. Clinical evaluation of efficacy of Khadirarishta and Kanchanara guggul the management of Uterine Fibroid -An exploratory study
40. Clinical evaluation of Punarnava Guggulu and Rasna Saptaka Kashaya in the management of Rheumatoid Arthritis (Amavata)
41. A  Clinical  evaluation  of  Triphala  Guggulu  and  Kasisadi  Taila  in management of Arsha (Haemorrhoids)
42. Therapeuti c  evaluation  of  Rasnadi  Gutika  and  Chandrakala  lepa  in Janusandhigata vata (Osteoarthritis)
43. Clinical evaluation of Kaishore Guggulu and Madhusnuhi Rasayana  in th management of Gout (Vatarakta)
44. Clinical  evaluation  of  Abhadya  Churna  and  Muktashukti  Bhasma in  the management of Osteopenia / Osteoporosis (Asthikshaya)
45. Clinical  evaluation  of  Laksha  Guggulu  and  Muktashukti    Bhasma  in  th management of Osteopenia/Osteoporosis
46. Clinical Evaluation of Certain Ayurvedic Formulations In The Management of Sthoulya (Obe sity)
47. Clinical evaluation of Mandura vataka  in the management of Pandu  (I deficiency Anaemia)
48. Clinical  evaluation  of  Sukumara  Ghritam  and  Brahmi  churnam  in  the management of Menopausal syndrome
49. Clinical  evaluation  of  Kalyanak  Ghrita  in  the  managemen t  of  Cognitive Deficit (Smriti Daurbalya).
50. Clinical evaluation of the efficacy of Trayodashanga Guggulu, Maharasna Kwatha and Prasarani Taila in the management of Gridhrasi (Sciatica)
51. Clinical  Evaluation  of  Rasnadi  Kvatha  churna  (Maha),  Trayodashanga Gug gulu and Brihatsaindhavadya Taila in the Management of Osteoarthrit of Knee (Janugata Sandhivata)
52. Assessment  of  therapeutic  efficacy  and  safety  of  Sitopaladi  Churna  w Madhu in the management of Kasa (Stable Chronic Bronchitis)
53. Clinical  efficacy  of  Ta lisadi  Churna  in  the  management  of  Kasa  (Stable Chronic Bronchitis)
54. Clinical evaluation of Haridrakhand and Triphala Kwath in the managemen of chronic Allergic Conjunctivitis (Kaphaja Abhishyanda)
55. A  Pilot  Evaluation  of  Safety  and  Efficacy  of  an  Ayurvedic Formulation (AYUSH - 64) for accelerating the recovery in cases of Influenza like Illness.
56. Clinical evaluation of Panchamrit Lauha Guggulu  and Panchgunataila the management of Cervical Spondylosis (Greevagraha)
57. Clinical  Evaluation  of  Ayurvedic formulations  in  the  management  of Parikartika (Fissure in Ano)
58. Observation  on  Fistula  cutting  Time  with  Ksharsutra  used  in  rout patients of Anorectal Fistula (Bhagandara)
59. Clinical Evaluation of Kantakaryavaleha and Eladi Gutika Management of Mild Stable Bronchial Asthma (Tamaka Shwasa)

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60. Clinical evaluation of AYUSH - PE eye drops in the management of Acute Allergic Conjunctivitis.
61. Clinical  evaluation  of  an  Ayurvedic  formulation  in  the  management Allergic Rhinitis - a pilot study
62. Clinical evaluatio n of Sapthasaram Kashayam & Saraswatharishtam in the management of Primary Dysmenorrheoa -An Exploratory study
63. Clinical  Evaluation  of    Efficacy  of  Indukanta  Ghrita  and  Trayodasha Guggulu in the  Management of Rheumatoid Arthritis vis -a -vis Amavata.

## Ongo ing

1. Clinical  evaluation  of  Varunadi  Kwath  and  channdraprabha  vati  in  t management of Mutrasmari (Urolithiasis)
2. Clinical evaluation of Shvadamstradi Kashaya and Hajarulayahud Bhasma in the management of Mutrasmari (Urolithiasis)
3. Clinical  efficacy  of  Kais hore  Guggulu  and  Balaguduchyadi  taila  in  the management of Gout (Vatarakta)
4. Clinical evaluation the efficacy of Pushyanuga Churna in the management Swetapradra (leucorrhoea) w.s.t. Bacterial Vaginosis
5. Clinical  efficacy  of  Drakshavelaha  in  the  management of  Pandu  (Iron Deficiency Anemia)
6. Clinical  efficacy  of  Drakshasava  in  the  management  of  Pandu  (Iro Deficiency Anemia)
7. Clinical evaluation of Eladi Churna and Draksharishta in the management Kasa
8. Clinical Evaluation of Varunadi Kwanth Churna and Apamar ga Kshara in the Management of Mutrashmari  (Urolithiasis)
9. Clinical evaluation of Shadbindu Taila Nasya and Chitraka Haritaki in management of Pinasa (Chronic Rhinosinusits)
10. A  clinical  study  on  efficacy  and  safety  of  an  Ayurvedic  formulat Kutajavleh a in the management of Grahani
11. Clinical  evaluation  of      Pathyadi  Kwatha  and  Anu  Taila  Nasya    in management of Migraine
12. Clinical  evaluation  of  Chitrak  Hariktaki  and    Lavangadi  Vati    in management of  Kaphaja Kasa (Stable Chronic Bronchitis)
13. Clinical evaluation off Agashtya haritaki Rasayana and Apamarga Kshara in the management of mild stable Bronchial Asthma
14. A  Clinical evaluation of Jirakadyarishta in the management of Mutrasm (Urolithiasis)
15. Clinical  evaluation  of  Mustakarishta  in  the  management of  Grahani (Malabsorption Syndrome)
16. Randomised placebo controlled double blind clinical trial on the effic AYUSH  MANAS  in  the  management  of  Smriti  Dourbalya  (Cognitive deficit)
17. Clinical  Evaluation  of  the  effect  of  Satavari  Guda  in  the  management Dysfunctional Uterine Bleeding (Asrigdara)
18. Clinical evaluation of the efficacy of Pushyanuga Churna and Ushirasava the management of Asrigdara (Dysfunctionl Uterine Bleeding)
19. Clinical  Evaluation  of  Triphala  Ghrita  as  topical  (Tarpana)  and  int medication in the management of Dry Age Related Macular Degeneration Symptoms.
20. Clinical evaluation of Narikela Lavana and Amalaki Churna in management of Amlapitta (Hyperacidity/Non ulcer dyspepsia)
21. Clinical  evaluation  of  Panchatikta  Ghrita  and  Nalpamaradi Taila  in  the management of Vicharchika (Eczema)
22. Efficacy of Ayurvedic intervention in the management of occupational st among IT professionals.
23. Clinical  evaluation  of  Panchatikta  Ghrita  &  Nalapamaradi  taila  in management of Psoriasis (Kitibha)
24. Cli nical  evaluation  of  Jatiphaladya  Churna  &  Chitrakadi  Gutika  in management of Grahani (Malabsorption Syndrome)
25. Clinical evaluation of of Panchatikta Ghrita and Gandhakadya Malahara the management of Vicharchika (Eczema)

## Collaborative Clinical Resea rch Projects

## Completed

1. Multi - centric  double  blind  randomized  controlled  clinical  trial  of  c drug AYUSH - Manas in Mental retardation (Manasa mandata) in children
2. A  Pilot  Study  Evaluating  Quality  of  Life  with  AYUSH  QOL -2C  in Patients  of  Local  Non - Metast atic  Breast  Cancer  Treated  with  Adjuvant Chemotherapy/Radiotherapy and Correlating it with Molecular Marker.
3. Collaborative Multicentric Clinical Trial  to Study the Effect of Rasayana (A&B) on Ageing in Apparently Healthy Elderly Subjects
4. Compara tive clinical evaluation of Ksharasutra prepared manually and automated machine in fistula - in - ano (Bhagandara)
5. Development and validation of Prakriti Assessment Questionnaire/ Scale
6. Controlled Clinical Trial to assess the effectiveness of topical appli cation of C l herbal oil on superficial external wound and split thickness ski donor's site for surgical wound healing

## Ongoing

1. Evaluation of Add on Efficacy & Safety of an Ayurvedic coded Formulatio in the management of Dengue Fever & Prevention of its complications
2. A Randomized Placebo Controlled Prospective Phase II Clinical Study of Ayurvedic  Coded  Drug  'AYUSH -D'  on  Glycemic  control  in  Pre - Diabetic Subjects (Collaborative)
3. A Randomized Placebo Controlled Prospective Phase II Clinical Study o f an Ayurvedic Coded Drug 'AYUSH -D' in the management of Type 2 Diabetes Mellitus as add on Therapy to Metformin (Collaborative)
4. Validation and Reliability Testing of Ayurveda Diagnostic Methods
5. A  phase  II  trial  to  study  efficacy,  toxicity  and  imunomodulat ory effect of Carctol - S  in high grade serous epithelial ovarian cancer at first serol relapse collaborative project.
6. Feasibility of introducing Ayurveda intervention in Reproductive and C Health (RCH) in PHCs of selected district of Maharashtra ( effectiveness of Ayurvedic intervention for Ante - Natal care (Garbhini Paricharya) at Primary Health Care Level: A Multi - Centre Operational Study).
7. Multi - centric collaborative Placebo controlled study on clinical evaluat Ayush SL in chronic Filarial L ymphoedena in patients receiving mass drug administration.
8. CSIR - Central  Institute  of  Medicinal  &  Aromatic  Plants  (CSIR - CIMAP), Lucknow;  and  CSIR - National  Botanical  Research  Institute  (CSIR - NBRI), Lucknow  had  taken  up  trial  on  a  proprietary  anti - diabetic  fo rmulation  at Banaras Hindu University, Banaras.
9. CSIR - Indian  Institute  of  Integrative  Medicine  (CSIR - IIIM),  Jammu  and Central Council of Research in Ayurveda Sciences (CCRAS) are conducting following studies:
10. Ashwagandha  for  the  Prophylaxis  against  SARS - CoV - 2  Infection:  A Randomized  Hydroxychloroquine  Controlled  Clinical  Trial  in  Health Care Providers;
11. A Randomized, Open Label, Parallel Efficacy, Active Control, Multi -Centre  Exploratory  Drug  Trial  to  Evaluate  Efficacy  and  Safety Ayurvedic formulation - 2 ( T. cordifolia + P. longum ) as Adjunct Treatment to Standard of Care for the management of Mild to Moderat COVID - 19 Patients; and
12. A Randomized, Open Label, Parallel Efficacy, Active Control, Multi -Centre  Exploratory  Drug  Trial  to  Evaluate  Efficacy  and Safety  of Ayurvedic  formulation - 3  (Glycyrrhizaglabra)  as  Adjunct  Treatment  to Standard of Care for the management of Mild to Moderate COVID - 19 Patients .