Lok Sabha Question No. 246 (UNSTARRED), answered on 2023-02-03
Subject: Development of Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Gowdar Mallikarjunappa Siddeshwara

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 246 TO BE ANSWERED ON 3 RD  FEBRUARY, 2023

## DEVELOPMENT OF AYURVEDIC MEDICINES

## 246. SHRI G.M SIDDESHWAR:

Will the Minister of AYUSH be pleased to state:

- (a) whether the Government proposes to introduce Indian system of Ayurveda medicines as an effective treatment for lifestyle diseases in view of its increasing popularity;
- (b) if so, the steps taken by the Government in this regard;
- (c) whether the Government proposes to develop the effective Ayurvedic medicines on a large scale; and
- (d) if so, the details thereof alongwith the efforts made in this direction?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

- (a) The Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body  under  Ministry  of  Ayush  has  undertaken  research  studies  on  the  lifestyle disease conditions viz. Diabetes Mellitus, Dyslipidemia, Non Alcoholic fatty liver Disease  (NAFLD),  Hypertension,  Irritable  Bowel  Syndrome,  Obesity,  Bronchial Asthma,  Osteoarthritis  and  Osteoporosis  and  PCOS  for  validation  of  Classical Ayurvedic  medicines  for  their  clinical  safety  and  efficacy.  Besides,  Council  has undertaken development of Ayurvedic formulations for lifestyle diseases through Systematic process of drug development
- (b) The details are given at Annexure-I
- (c) CCRAS has developed 'AYUSH-82' an Anti-Diabetic Ayurvedic formulation for management of Diabetes and commercialized through National Research Development Corporation (NRDC) for wider public utility. AYUSH 82 technology has  been  transferred  to  11  manufacturing  units.  CCRAS  has  undertaken  the development  of  the  various  coded  formulations  viz.  AYUSH  A  for  Bronchial Asthma, AYUSH D for Type II Diabetes Mellitus, Ayush CCT in clinical recovery in post- operative cardiac care , Ayush GMH for Non Alcoholic fatty liver Disease (NAFLD)  ,  Ayush  M-3  for  pre-hypertension,  Ayush  HR  in  Pre-  Hypertension, Ayush PTK for hepatoprotection as adjuvant to ATT, Ayush Manas in Cognitive deficit, Ayush SR in Occupational stress   and CARCTOL-S in ovarian Cancer which are at different phases of drug development.
- (d) The details are given at Annexure-II

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## Disease conditions and corresponding projects undertaken by CCRAS

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|   S. N o | Disease Condition   | Name of the Project                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|----------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | Diabetes Mellitus   | 1. NPCDCS(National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases & Stroke) in three districts,viz. Surendranagar (Gujarat), Bhilwara (Rajasthan), Gaya (Bihar)to demonstrate the feasibility of integration of Ayurveda involving 49 CHCs, 3 District Hospitals, and 189 PHC- Completed 2. Clinical evaluation of Saptavimshatika Guggulu and Haridra Churna in the management of type II Diabetes Mellitus- completed 3. Clinical Evaluation of Nisha Amalaki and Chandraprabha Vati in the management of Type II Diabetes Mellitus (Madhumeha)- completed 4. Clinical Evaluation of Nisha Katakadi Kashaya and Yashada Bhasma in the Management of Type II Diabetes Mellitus(Madhumeha)- completed 5. Clinical evaluation of Gokshuradi Guggulu and Guduchi churna in the management of Madhumeha (Type II Diabetes Mellitus)- completed 6. Clinical Evaluation of the Efficacy and Safety of Mamajjaka Ghanavati in Madhumeha (Type 2-Diabetes)- completed |
|        2 | Dyslipide mia       | 1. Clinical evaluation of Vyoshadi Guggulu and Haritaki Churna in the management of Dyslipidemia- Completed 2. Efficacy and safety of Ayurveda Formulation 'Trikatu' as add-on to standard care in Dyslipidemia- A Prospective Randomized Double Blind Placebo Controlled Trial- Ongoing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|        3 | Hypertensi on       | 1. Clinical evaluation of Ashvagandhadyarishta, Jatamamsi Arka and Sarpagandha Vati in the management of essential Hypertension-Completed 2. Clinical evaluation of Parthadyarishtha (Arjunaristha) and Sarpagandha Vati in the management of Essential Hypertension (Uccha Raktachaap)- Completed 3. Clinical evaluation of Rudraksha Churna in the management of Essential Hypertension (Uccha Raktachaapa)- Completed                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |

|    |                          | 4. Prospective double blind randomized controlled clinical study on Ayurvedic intervention (Sarpagandha Mishran) vs. Amlodipine in the management of stage-I Primary Hypertension- Ongoing                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |
|----|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  4 | Irritable Bowel Syndrome | 1. Clinical evaluation of Bilvadi Leha in the management of Irritable Bowel Syndrome- Completed 2. Clinical Evaluation of Kutajarishta In The Management of Irritable Bowel Syndrome (IBS)-Completed 3. Clinical efficacy and safety of Brihat Gangadhara Churna in the management of Irritable Bowel Syndrome- Completed                                                                                                                                                                                                                                                                                                                                              |
|  5 | Obesity                  | 1 Clinical evaluation of Vyoshadi Guggulu and Haritaki Churna in the management of Obesity-Completed 2 Clinical Evaluation of Vidanga Churna and Vyoshadi Guggulu in the Management of Medoroga (Obesity) - Ongoing 3 Clinical Evaluation of Lekhaniya Gana Kashaya and Arogyavardhini Gutika in the management of Medoroga (Obesity)- Ongoing                                                                                                                                                                                                                                                                                                                         |
|  6 | Bronchial Asthma         | 1. Clinical Evaluation of Kantakaryavaleha and Eladi Gutika in the Management of Mild Stable Bronchial Asthma (Tamaka Shwasa)- Completed 2. Clinical evaluation of Agashtya Haritaki Rasayana and Apamarga Kshara in the management of Mild Stable Bronchial Asthma (Tamaka Shwasa)- Completed 3. Clinical evaluation of Vyaghri Haritaki in the management of Bronchial Asthma- Completed 4. Clinical evaluation of Kanakasava and Trivrita Churna in the management of Bronchial Asthma (Tamaka Swasa)-                                                                                                                                                              |
|  7 | Osteoarthr itis          | Completed 1. Clinical Evaluation of Rasnadi Kvathachurna (Maha), Trayodashanga Guggulu and Brihatsaindhavadya Taila in the Management of Osteoarthritis of Knee (Janugata Sandhivata)- Completed 2. Clinical evaluation of Punarnava Guggulu, Dashmoola Ghrita and Kottamachukadi Taila in the management of Osteoarthritis- Completed 3. Clinical evaluation of Vatari guggulu, Maharasnadi kwatha and Narayana taila in the management of Osteoarthritis knee- Completed 4. Clinical Evaluation of Ksheerbala Taila Matra Basti, Therapeutic Combination of Vatari Guggulu, Maharasnadi Kwatha and Narayan Taila in the Management of Osteoarthritis Knee- Completed |

|    |               | 5. Clinical Evaluation of Yogaraj Guggulu, Gandharvahasta Taila and Dhanwantara Taila in the management of Osteoarthritis knee- Completed 6. Therapeutic evaluation of Rasnadi Gutika and Chandrakala lepa in Janusandhigata vata (Osteoarthritis)- Completed 7. A randomized trial to evaluate the efficacy of multimodal Ayurveda interventions in Jannu Sandhigatavata (Primary Knee - osteoarthritis)- Ongoing                                                                                                 |
|----|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  8 | Osteoporo sis | 1. Clinical evaluation of Abhadya Churna and Muktashukti Bhasma in the management of Osteopenia / Osteoporosis (Asthikshaya)- Completed 2. Clinical evaluation of Laksha Guggulu and Muktashukti Bhasma in the management of Osteopenia/Osteoporosis- Completed 3. Clinical evaluation of Laksha Guggulu and Mukta Shukti Pishti in the management of Osteopenia/Osteoporosis- Completed 4. Clinical Evaluation Of Ashwagandha Churna and Pravala Pishti in the Management of Osteopenia / Osteoporosis- Completed |
|  9 | PCOS          | 1. Clinical evaluation of the efficacy of Rajahpravartini vati, Kanchanar guggulu and Varunadi kashaya in the management of Polycystic Ovary Syndrome (PCOS): A pilot study- Completed                                                                                                                                                                                                                                                                                                                             |

## List of Ayurvedic Formulations under Drug Development in Lifestyle diseases

|   S. No. | Ayurvedic medicine & Disease Condition                        | Name of the Project                                                                                                                                                                                                                                                                                                                                                                          |
|----------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | AYUSH-A for Bronchial Asthma                                  | 1. Randomized double blind placebo controlled clinical study Ayurvedic coded drug AYUSH-A in the management of Bronchial Asthma (Tamaka Shwasa)- Ongoing                                                                                                                                                                                                                                     |
|        2 | AYUSH-D for Type 2 Diabetes Mellitus                          | 1. A Randomized Placebo Controlled Prospective Phase II Clinical Study of an Ayurvedic Coded Drug 'AYUSH-D' on Glycemic control in Pre- Diabetic Subjects (Collaborative)- Completed 2. A Randomized Placebo Controlled Phase II Clinical Study of an Ayurvedic Coded Drug 'AYUSH-D' in the management of Type 2 Diabetes Mellitus as add on Therapy to Metformin (Collaborative)- Completed |
|        3 | Ayush CCT in clinical recovery in post operative cardiac care | 1. Randomized control study to evaluate the efficacy of Ayush CCT and Rajyoga Meditation versus conventional treatment on clinical recovery and post operative outcome following elective cardiothoracic surgeries- Completed                                                                                                                                                                |
|        4 | Ayush-GMH for Non Alcoholic Fatty Liver Disease (NAFLD)       | 1. Evaluation of Ayush-GMH in the subjects of mild to moderate Non alcoholic fatty liver disease (NAFLD)-A double blind randomized control clinical study- Ongoing                                                                                                                                                                                                                           |
|        5 | AYUSH - M3 for Pre-Hypertension                               | 1. Evaluation of efficacy and safety AYUSH- M3 in the management of Pre-Hypertension- A double blind randomized control clinical study- Ongoing                                                                                                                                                                                                                                              |
|        6 | AYUSH- HR in Pre-Hypertension                                 | 1. Evaluation of efficacy and safety AYUSH- HR in the management of Pre-Hypertension- A double blind Randomized control clinical study- Ongoing                                                                                                                                                                                                                                              |
|        7 | Ayush PTK for hepatoprotection as adjuvant to ATT             | 1. Evaluation of Hepatoprotective activity of PTK as an add on therapy in the patients of Tuberculosis on ATT - A double blind randomized control clinical study- Ongoing                                                                                                                                                                                                                    |
|        8 | AYUSH MANAS in Congnitive Deficit                             | 1. Randomized Placebo Controlled Double Blind Clinical Trial on the Efficacy of AYUSH MANAS in the management of Smriti Daurbalya (Congnitive Deficit)- Ongoing                                                                                                                                                                                                                              |

|   9. | Ayush-SR in Occupational Stress   | 1 Evaluation of Ayush-SR Tablet in Occupational Stress among IT professionals -A Randomized double blind placebo controlled clinical study- Ongoing 2 Evaluation of AYUSH-SR Tablet in Occupational stress Among Nurses- A Randomized Double Blind Placebo Controlled Clinical Study- Ongoing   |
|------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   10 | Carctol-S in ovarian cancer       | 1. A phase II trial to study efficacy, toxicity and imunomodulatory effect of Carctol-S in high grade serous epithelial ovarian cancer at first serological relapse collaborative project- Ongoing                                                                                              |

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