Lok Sabha Question No. 1094 (UNSTARRED), answered on 2023-12-08
Subject: Research Study on Medicinal Plants
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Chandra Sekhar Bellana

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1094 ANSWERED ON 08.12.2023

'Research Study on Medicinal Plants'

## 1094. SHRI CHANDRA SEKHAR BELLANA:

Will the Minister of AYUSH be pleased to state:

(a) whether the government has recently commissioned any research study on medicinal plants regarding their uses to treat modern diseases and if so, details thereof;

(b)  whether  the  government  is  aware  of  the  research  study  published  in  the  World  Journal  of Diabetes  stating  that  evidence  based  trials  in  natural  products  could  lead  to  development  of 'novel drugs in the modern management of Diabetes' with over 400 medicinal plants having the potential to combat Type-2 Diabetes;

(c)  if  so,  whether  the  government  has  taken/  proposed  to  take  any  steps  to  generate  more research on this in view of the increasing number of diabetic patients in India; and

(d) if so, the details thereof?

## ANSWER

## THE MINISTER OF AYUSH

## (SHRI SARBANANDA SONOWAL)

Ans. (a): Yes, Sir. The Ministry of Ayush, through its various Research Councils, are actively involved in research on various aspects of medicinal plants, including their uses to treat modern diseases.

Central Council for Research in Ayurvedic Sciences (CCRAS),  an autonomous institution  under the Ministry of Ayush, has been actively  engaged in comprehensive research

activities  in  Ayurveda,  including  clinical  research.  An  objective  of  CCRAS  is  to  generate  a robust evidence base for the safety and efficacy of Ayurveda formulations and medicinal plants in addressing various diseases and conditions such as osteoarthritis, rheumatoid arthritis, stroke rehabilitation, infertility, osteoporosis, insomnia, bronchial asthma, parkinson's disease, dyslipidemia,  psoriasis,  hypothyroidism,  COVID-19    etc.  through  robust  research.  This  also includes  exploring  traditional  knowledge  and  modern  scientific  methodologies  to  assess  the therapeutic potential of medicinal plants. Details are placed in Annexure-I.

Central Council for Research in Homoeopathy (CCRH), through its National Institute of Homoeopathy (NIH), Kolkata has been engaged and conducted a fundamental research work on COVID-19 by using ' Cinchona officinalis '  (Homoeopathic  preparation)  in  collaboration  with National Institute of Pharmaceutical Education and Research (NIPER), Kolkata. In silico and in vitro evidence on the mother tincture of Cinchona officinalis has promising antiviral properties against SARS-COV-2 infection.

National Institute Siddha (NIS), has conducted various clinical studies with good clinical outcomes, viz. (i) Manjitti kudineer , Siddha herbal concoction in non-healing diabetic and nondiabetic  foot  ulcers  and  bedsores;  (ii)  NIS  has  initiated Venthamarai  churnam randomized controlled clinical trial in collaboration with Directorate of Public Health, Govt. of Tamil Nadu; (iii)  NIS has evaluated herbal concoctions Kabasura Kudineer , Adathodai Kudineer and Nochi Kudineer against mild, moderate and severe COVID-19 through randomized controlled clinical trials.  Further,  NIS  has  completed  clinical  trials  in  diabetes  and  prediabetes  patients  with Aavaarai  Kudineer in  a  project  made  through  grant  support  from  the  Tamil  Nadu  State Department of Science & Technology under the DST of Govt. of India and published papers.

Further, various organizations in the country, like the Council of Scientific & Industrial Research (CSIR), Indian Council of Medical Research (ICMR) and Department of Biotechnology  (DBT),  are  also  actively  involved  in  research  studies  on  medicinal  plants regarding their uses to treat modern diseases.

CSIR  constituent  laboratory,  CSIR-NEIST,  has  been  working  on  one  project  entitled 'Bio-evaluation and identification of lead molecules for Lung and Colon cancer from selected Medicinal Plants'  for  study  on  medicinal  plant  and  their  uses  to  treat  modern  diseases.  Also, CSIR's constituent laboratory, CSIR-IIIM, is actively involved in antidiabetic drug discovery and development from natural as well as semi-synthetic sources. CSIR-IIIM has programs to develop natural  product-driven  drug  candidates  for  disorders  such  as  diabetes  mellitus  and  obesity. Currently,  the  lab  is  investigating  natural  and  semi-synthetic  compounds  from  plants  such as Parthenium hysterophorus , Andrographis paniculata and Marrubium vulgare for their antiinflammatory and antidiabetic activities. The institute is also pursuing research and developmental work on Bergenia ciliata for treating rheumatoid arthritis and Crocus sativus for neurodegenerative disorders.

The Department of Biotechnology (DBT) has been providing funding support to conduct R&D  in  important  medicinal  and  aromatic  plants  at  various  institutions/  universities/  other organizations in Pan-India on various aspects of medicinal plant research. The Department has also  supported  the  establishment  of  antiviral  screening  facilities  for  novel  molecules  against COVID-19 and other viral diseases at the Institute of Life Sciences (ILS), Bhubaneswar and the Institute for Stem Cell Science and Regenerative Medicine (InSTEM), Bangalore.

Indian Council of Medical Research (ICMR) has commissioned several recent studies on medicinal plants for treating modern diseases, including projects such as:

- i. Developing a standardized formulation of Trigonella foenum-graecum seeds for preventing Type-2 diabetes.
- ii. Formulating treatments for sleep disorders using Nardostachys jatamansi and Withania somnifera.
- iii. Studying  the  antiarthritic  potential  of Holoptelia  integrifolia and Plumbago  zeylanica documenting genetic and phytochemical variations in Gymnema sylvestre.
- iv. Evaluating the efficiency of herbal anti-diarrheal agents.
- v. Assessing  the  anti-inflammatory  and  analgesic  activities  of Plumbago  zeylanica in osteoarthritis.
- vi. Validating  the  diabetic  wound  healing  activity  of  essential  oil  from Mammea  suriga flower buds.
- vii. Evaluating the role of Gymnemagenin in regulating glucocorticoid action.
- viii. Identifying  potential  herbal  drug  candidates  from  traditional  practices  against  viral hepatitis through preliminary in-silico screening.

In addition, the National Medicinal Plants Board (NMPB), Ministry of Ayush, under its Central  Sector  Scheme  on  'Conservation,  Development  and  Sustainable  Management  of Medicinal  Plants'  provides  project-based  financial  support  to  carry  out  research  activities  on various  aspects  of  medicinal  plants  to  government  as  well  as  private  universities/research institutions/organizations  across  the  country.  Details  of  the  project  supported  in  the  last  three years are in Annexure-II.

Further, to explore the possibility of cooperation, convergence and synergy and to bring biotechnological  intervention  into  the  AYUSH  sector,  the  National  Medicinal  Plant  Board (NMPB), Ministry of AYUSH and DBT signed an MoU on 31.12.2018. Under this, joint R&D projects were supported in a network mode to evaluate medicinal plants and preparations against the  SARS-Cov-2  virus  and  COVID-19  infection.  These  projects  were  implemented  at  the following institutes:

- i. Regional Centre for Biotechnology (RCB), Faridabad
- ii. Institute of Bioresources & Sustainable Development (IBSD), Imphal
- iii. Jadavpur University, Kolkata
- iv. Translational Health Science and Technology Institute (THSTI), Faridabad

- v. Institute of Life Sciences (ILS), Bhubaneswar
- vi. Kalinga Institute of Industrial Technology (KIIT), Bhubaneswar
- vii. Regional Plant Research Centre (RPRC), Bhubaneswar.

(b,  c  &  d). Yes, Sir.  Various  established Research  Institutes  /  Centres  /  Units  under  different Research Councils of the Ministry of Ayush, Government of India, are already actively engaged in diabetes and associated complications. Details are appended in Annexure-III.

Apart from this, other various organizations in the country, like the Council of Scientific & Industrial Research (CSIR), constituent laboratory CSIR-Institute of Himalayan Bioresource Technology  (CSIR-IHBT),  conducting  and  supporting  antidiabetic  research  to  generate  more data  on  tea  catechins,  Epigallocatechin  gallate  (EGCG),  Phlorizin  as  well  as  its  derivative Phloretin.  Also,  the  CSIR-Indian  Institute  of  Integrative  Medicine  (CSIR-IIIM)  is  involved  in developing natural product-driven drugs for disorders such as diabetes mellitus.

Indian  Council  of  Medical  Research  (ICMR)    has  published  one  monograph  on  the potential of medicinal plants in diabetes management entitled 'Perspectives of Indian Medicinal Plants  in  the  Management  of  Diabetes  Mellitus'-Indian  Council  of  Medical  Research,  New Delhi. Further, ICMR has initiated a phase-I clinical study on the phytopharmaceutical product of Trigonella  foenum-graecum seeds  in  the  prevention/  treatment  of  type-2  diabetes  in  2022, which will be completed by January 2024.

## Annexure-I

## Recent research studies performed by CCRAS on medicinal plants regarding their uses in treating modern diseases.

## I. Intra Mural Clinical Research (IMR) Projects

1. Clinical  evaluation  of eladi  churna and draksharishta in  the  management  of kasa (stable chronic bronchitis).
2. Clinical evaluation of the efficacy of pushyanug churna in the management of sweta pradara w.r.t. Bacterial vaginosis (leucorrhoea).
3. Clinical  study  on  efficacy  and  safety  of  an  ayurvedic  formulation kutajavleha in  the management of grahani roga .
4. Clinical evaluation of svadamshtradi kashaya and hajarulayahuda bhasma in the management of mutrashmari (urolithiasis).
5. Clinical evaluation of drakshasava in the management of pandu (iron deficiency anaemia).
6. Clinical  evaluation  of shadbindu  taila nasya  and chitraka  haritaki in  the  management  of pinasa (chronic rhinosinusitis).
7. Clinical evaluation of pathyadi  kwatha and anu  taila  nasya in  the  management  of ardhavabhedaka (migraine).
8. Clinical evaluation of the efficacy of pushyanuga churna and usheerasava in the management of abnormal uterine bleeding.
9. Clinical  evaluation  of jatiphaladya  churna & chitrakadi  gutika in  the  management  of grahani.
10. Clinical evaluation of panchatikta ghrita and gandhakadya malahara in the management of vicharchika (eczema).
11. Clinical evaluation of chitraka haritaki and lavangadi vati in the management of kaphaj kasa (stable chronic bronchitis).
12. Clinical evaluation of agashtya haritaki rasayana and apamarga kshara in the management of mild stable bronchial asthma ( tamaka shwasa ).
13. Clinical efficacy of kaishore guggulu and balaguduchyadi taila in  the management of gout ( vatarakta ).
14. Clinical  evaluation  of  the  efficacy  of soubhaya shunthi paka  and dashmularishta in sutika paricharya (post natal care).
15. Clinical evaluation of drakshavaleha in the management of pandu (iron deficiency anaemia).
16. Clinical  evaluation  of shatavari  guda and ashokarishta in  the  management  of asrigdara (abnormal uterine bleeding).
17. An  open  label  clinical  trial  to  evaluate  clinical  efficacy  and  safety  of  AYUSH  AGT  in dandruff ( darunaka ).
18. Clinical evaluation of varunadi kwath churna and apamarga kshara in  the  management of mutrashmari (urolithiasis).

19. Clinical  evaluation  of  ayurvedic  formulations puga  khanda and  AYUSH  PVK  gel  in  the management of swetapradara (pathological leucorrhoea).
20. Clinical evaluation of nimbatiktam and lajjalu keram gel in the management of psoriasis.
21. Clinical evaluation of lavanbhaskara churna in the management of amajirna - a randomized parallel group study.
22. Clinical  evaluation  of panchatikta  ghrita and  nalpamaradi  taila  in  the  management  of vicharchika (eczema).
23. Clinical evaluation of jirakadyarishta in the management of grahani .
24. Clinical  evaluation  of panchatikta  ghrita & nalpamaradi  taila in  the  management  of psoriasis.
25. Clinical evaluation of mustakarishta in the management of grahani.
26. Clinical evaluation of vajra kshara in  the management of amajirna -  a  randomized parallel group study.
27. An  open  label  clinical  trial  to  evaluate  clinical  efficacy  and  safety  of  AYUSH  AGT  for external wounds.
28. Clinical  evaluation  of  the  efficacy  of varunadi  kwatha and chandraprabha  vati in  the management of mutrasmari (urolithiasis).
29. Clinical evaluation of lohasava and amalaki churna in the management of pandu roga ( iron deficiency anaemia ) .
30. Clinical  evaluation  of  ayurvedic  formulations shatavari  gudam & triphala  kashaya in shwetapradara (leucorrhoea).
31. Randomised  placebo  controlled  double  blind  clinical  trial  on  the  efficacy  of  AYUSH MANAS in the management of smriti daurbalya (cognitive deficit).
32. Evaluation of AYUSH-SR tablet in occupational stress among it professionals -a randomized double blind placebo controlled clinical study.
33. Evaluation of AYUSH-SR tablet in occupational stress among nurses- a randomized double blind placebo controlled clinical study.
34. Evaluation  of  efficacy  and  safety  AYUSH-  M3  in  the  management  of  pre-hypertension-  a double blind randomized control clinical study.
35. Effectiveness  of  the  role  of astangalavana and srikhandasava as  add  on  treatment  of madatyaya (alcohol dependence) -an open level clinical trial.
36. Clinical evaluation of gokshuradi guggulu and nimbadi churna in vatarakta (gout).
37. Clinical evaluation of vidanga churna and vyoshadi guggulu in the management of medoroga (obesity).
38. Clinical  evaluation  of khadirarishta,  kaishore  guggulu and gandhakadya  malahar in  the management of vicharchika (eczema).
39. Evaluation  of  efficacy  and  safety  AYUSH-  HR  in  the  management  of  pre-hypertension-  a double blind randomized control clinical study.
40. Clinical efficacy and safety of arogyavardhani vati and pippalyasava in the management of non-alcoholic fatty liver disease (NAFLD)- an open label prospective clinical trial.

41. A randomized, placebo controlled, double blind clinical trial to evaluate the effect of trikatu in subclinical hypothyroidism.
42. Clinical evaluation of lekhaniya gana kashaya and arogyavardhini gutika in the management of medoroga (obesity).
43. Clinical evaluation of lashunadi vati and pippaladyasava in the management of agnimandya.
44. Clinical  evaluation  of triphala  ghrita as  topical  ( tarpana )  and  internal  medication  in  the management of dry age related macular degeneration symptoms.
45. Efficacy  and  safety  of  Ayurveda  formulation  ' trikatu '  in  dyslipidemia  -  a  prospective randomized double blind placebo controlled trial.
46. Clinical assessment of the efficacy of ayurvedic management in PCOS - a randomized open label control trial.
47. Clinical evaluation of nimbadi churna, khadirarista and arjuna lepa in  the management of acne ( yuvan pidika ).
48. Clinical evaluation of sanjivani vati and pippaladyasava in the management of agnimandya -a randomized parallel group study.
49. Topical oil pooling ( karnapurana ) with kshirabala taila and supple mentation of ashwagandha churna (topmac) in presbycusis - an exploratory randomized controlled trial.
50. Evaluation of the efficacy and safety of chandraprabha vati with gokshuradi guggulu in the management of benign prostatic hyperplasia - a randomized standard controlled clinical trial.
51. Clinical evaluation of ayurvedic regimen ( virechana karma followed by oral administration of kankayana vati, kanchanara guggulu and kumaryasava ) in the management of polycystic ovarian syndrome - a randomized controlled open label clinical trial.

## II. Collaborative Clinical research Projects

1. Evaluation of add on efficacy & safety of an ayurvedic coded formulation in the management of dengue fever & prevention of its complications - a double blind clinical study.
2. A randomized placebo controlled prospective phase II clinical study of an ayurvedic coded drug 'AYUSH-D' on glycemic control in pre-diabetic subjects (collaborative).
3. 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).
4. Multi-centric  collaborative  double  blind  study  on  clinical  evaluation  of  AYUSH-SL  in chronic filarial lymphoedema in patients receiving mass drug administration.
5. Feasibility of introducing Ayurveda intervention in reproductive and child health (RCH) in PHCS of selected district (gadchiroli) of maharashtra (effectiveness of ayurvedic intervention for  ante-natal  care  ( garbhini  paricharya )  at  primary  health  care  level:  a  multi  centre operational study).

6. Randomized control study to evaluate the efficacy of AYUSH CCT and rajyoga meditation versus  conventional  treatment  on  clinical  recovery  and  post  operative  outcomes  following elective adult cardiothoracic surgeries.
7. A  comparative  clinical  study  of  AYUSH-LND  a  coded  ayurvedic  formulation  in  the management of asrigdara (abnormal uterine bleeding).
8. Clinical  evaluation  of  the  efficacy  of  'Ayush  -  SS  granules'  in  exclusively  breast  feeding mothers with insufficient lactation ( stanyalpata )-a randomized double blind placebo control trial.
9. Evaluation  of  hepatoprotective  activity  of  PTK  as  an  add  on  therapy  in  the  patients  of tuberculosis on ATT - a double blind randomized controlled clinical study.
10. Study the physiological basis and gut bacterial modulations induced by virechana (purgation therapy) in healthy adults: a prospective longitudinal study.
11. Evaluating  the  efficacy  of  ayurvedic  intervention  as  add  on  to  conventional  treatment  and explore the interaction of epigenetics, neuro/gut  biomarkers and neuroimaging in pediatric ADHD (attention deficit hyperactivity disorder).
12. Prospective  double  blind  randomized  controlled  clinical  study  on  ayurvedic  intervention ( sarpgandha mishran ) vs amlodipine for the management of stage - I primary hypertension.
13. A  randomized  controlled  trial  to  evaluate  the  efficacy  of marma therapy  in  lumbar  disc herniation with radiculopathy.
14. Double blind randomized placebo controlled multicentric clinical trial of AYUSH M-3 in the management of migraine.
15. Evaluation  of  AYUSH-GMH in the subjects of mild to moderate non-alcoholic fatty liver disease (NAFLD)-a double blind randomized control clinical study.
16. A randomized controlled trial to evaluate the efficacy of multimodal Ayurveda interventions in jaanu sandhigatavata (primary knee osteoarthritis).
17. A pilot study to assess the effect of intranasal oil instillation ( pratimarsha nasya )  on  nasal barrier function among healthy individuals.
18. A  double  blind,  double  dummy  prospective  randomized  controlled  study  to  evaluate  the efficacy  of  classical  Ayurveda  management  versus  methotrexate  in  rheumatoid  arthritis(AMRA study).
19. Ayurveda  therapeutic  regiman  as  on  add-on  to  optimized  conventional  management  of parkinson's disease: an RCT for assessment of clinical cortical excitability neuroimmune and autonomic function parameters.
20. Efficacy  of  Ayurveda  nutritional  supplements  and  yoga  protocol  in  the  prevention  and reduction of the severity of  acute mountain sickness: an open-label randomized controlled study.

21. A randomized controlled study to assess the effect of marsha nasya karma in motor, sensory, memory and cognitive parameters elicited through F - MRI in apparently healthy individuals.
22. Efficacy  and  safety  of  Ayurveda  formulation trikatu as  add  on  to  standard  care  in dyslipidemia - a randomized controlled trial.
23. Efficacy  of  Ayurveda  regimen  (mild  purgation  and  internal  oleation)  in  comparison  with allopathic  regimen  (letrozole)  along  with  yoga  module  in  the  management  of  unexplained and anovulatory female infertility: a RCT.
24. Clinical  evaluation  of  ayurvedic  management  in  allergic  rhinitis-  a  randomized  controlled trial.

## III. COVID-19 related clinical research studies

1. Evaluation of the efficacy of an Ayurvedic intervention (chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel - An open label single arm prospective study.
2. Evaluation of Efficacy and Safety of Ayurveda Intervention (AYUSH  -64) in the management of COVID-19 infection (Asymptomatic & Mild to Moderate symptoms) - An open label single arm prospective clinical trial.
3. Evaluation of the efficacy of an Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 among Health Care Personnel - An open label single arm prospective study.
4. A Pilot Study to assess the efficacy of AYUSH - 64 in COVID - 19 Cases.
5. Evaluation of Efficacy and Safety of Ayurveda Intervention (AYUSH - 64) add-on-therapy for patients with Covid-19 infection (Stage-I) - A Randomized controlled clinical trial.
6. A Randomized, Open Label, Parallel Efficacy, Active Control, Exploratory Clinical  Trial to Evaluate  Efficacy  and  Safety  of  an  Ayurvedic  Formulation  (AYUSH  -  64)  as  Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients.
7. A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Ayurveda  Interventions  ( Ashwagandha Tablet  and Shunti Capsule)  in  the  management  of COVID-19 infection (Mild to Moderate symptoms).
8. A  Randomized,  Open  Label,  Parallel  Efficacy,  Active  Control,  Multi-Centre  Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation (AYUSH - 64) as adjunct Treatment to standard of care for the management of Mild to Moderate COVID-19 Patients.
9. A Study of Ashwagandha in the Prophylaxis Against COVID-19 and its benefits on General Health  in  High  Risk  Health  Care  Workers:  A  Randomized  Controlled  Comparison  with Hydroxychloroquine Sulphate (HCQS).

10. A  prospective  non-randomized  open  label  controlled  interventional  study  on  the  effect  of Guduchi  Ghan  Vati / Sudarshan  Ghan  Vati as  a  prophylactic  measure  among  high  risk population (Health Care Workers/Containment Zone population) exposed to COVID-19.
11. A prospective non-randomized open labeled controlled interventional study on the effect of Ashwagandha ( Withania somnifera )  as  a  prophylactic measure among high risk population (Health Care Workers/ Containment Zone Population) exposed to COVID-19.
12. A prospective non-randomized open labeled controlled interventional study on the effect of Chyavanprash Lehyam as a prophylactic measure among high risk population (Health Care Workers/ Containment Zone Population) exposed to COVID-19.
13. Prospective  non-randomized  open  labeled  controlled  interventional  study  on  the  effect  of Guduchi ( Tinospora  cordifolia )  as  a  prophylactic  measure  among  high  risk  population (Health Care Workers/Containment Zone Population) exposed to COVID-19.
14. Prospective  non  randomized  open  label  control  interventional  study  on  the  effect  of Ayurvedic Raksha Kit ( Chavanprash , Samsahmani vati & Haritaki ) as Prophylactic measure among police personal working in the vicinity of COVID -19 facilities.
15. Prospective  non  randomized  open  label  control  interventional  study  on  the  effect  of Ayurvedic Raksha Kit-1 (AYUSH-64, Samshamani vati & Chayvanprasha ) as Prophylactic measure among Ayush healthcare workers working in the vicinity of COVID -19 facilities
16. In-silico evaluation of compounds of an Ayurvedic drug, AYUSH-64, for their action against SARS-CoV-2 Main Protease.
17. Effect  of  an  Ayurvedic  formulation  as  add-on  therapy  to  Standard  of  Care  in  COVID-19 positive patients in a tertiary hospital.
18. A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Guduchi Ghan Vati in the management of COVID-19 infection.
19. A  prospective  open  label  controlled  interventional  study  on  the  effect  of  Ayurvedic intervention ( Ayurveda Raksha Kit) as a prophylactic measure in the Pandemic of COVID-19 - A community based study.
20. Impact  of  Ayurvedic  Interventions  in  prevention  of  COVID-19  infection  in  containment areas of Delhi- A community based study.
21. Impact of Ayurvedic intervention ( Guduchighan Vati ) in prevention of COVID-19 infection in containment areas of Himachal Pradesh-A community based study.
22. Documentation  of  efficacy  of  select  AYUSH  Interventions  AYUSH-64  and Kabasura Kudineer in asymptomatic & mild to moderate COVID-19 patients in home isolation through a mobile app: A prospective multicenter Community based study.
23. A  study  of Ashwagandha administration  in  participants  vaccinated  against  COVID-19  on safety,  immunogenicity  and  protection:  A  randomized,  double  blind,  placebo  controlled, multi-centric clinical trial.

## Annexure-II

## Details of the project supported on various aspects of medicinal plants, including their uses to treat modern diseases in the last three years, are as below:

|   Sr No | Project no      | Project title and organization details                                                                                                                                                     |   Sanctioned amount | Objectives                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|---------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | HP- 01/2021- 22 | In vivo and in vitro study on synergistic effect of medicinal plants in breast cancer of mice. Central University of Himachal Pradesh Shahpur Campus, Kangra, Himachal Pradesh PIN: 176206 |             40.1023 | 1. To study synergistic effect of Withania somnifera , Curcuma longa , Emblica officinale and Ocimum sanctum on histology, hormonal and biochemical parameters of mice having breast cancer. 2. To study micronuclear assay and chromosomal study in breast cancer and Withania somnifera , Curcuma longa , Emblica officinale and Ocimum sanctum plant extract treated group of mice. 3. To analyze the in vitro synergistic impact of Withania somnifera , Curcuma longa , Emblica officinale and Ocimum sanctum against breast cancer cells of mice. 4. To establish effective synergistic dose of Withania somnifera , Curcuma longa , Emblica officinale and Ocimum sanctum against breast cancer of mice Plant species: Withania somnifera, Curcuma longa, Emblica officinale and Ocimum sanctum . |
|       2 | TN- 02/2022- 23 | Deciphering the response of Ficus fruit polysaccharides on Major Histocompatibility                                                                                                        |             38.0525 | 1. Collection and authentication of different Ficus fruit species and further processing by hot water extraction, alcohol precipitation, ultrasonic-assisted extraction, and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |

| (MHC) in Inflammatory Bowel Disease (IBD). Department of Botany, Bharathiar University, Coimbatore, Tamil Nadu.   | Complex   |
|-------------------------------------------------------------------------------------------------------------------|-----------|

## Annexure-III

Details of Research activities have been undertaken by the various Research organizations/institutes across the country in the management of diabetes mellitus

## I. Central Council for Research in Ayurvedic Sciences (CCRAS)

## A. Clinical  studies  for  validation  of  Ayurveda  classical  medicines  in  the  management  of Type II diabetes mellitus

The Council has validated 08  Ayurveda classical  medicines viz . Saptavimshatika guggulu , Haridra  churna , Nisha  amalaki , Chandraprabha  vati , Nisha  katakadi  kashaya , Yashada bhasma , Gokshuradi  guggulu and Guduchi  churna apart  of Mamajjaka  ghana  vati in  the management of Type II diabetes mellitus to generate the tangible evidence on their clinical safety  and  efficacy.  The  research  outcomes  of  these  studies  have  been  published  in  peerreviewed journals as follows:

- a. Jain AK, Sharma SK, Sahu D, Kumawat VB, Sharma OR, Dua P et al . A multicenter clinical trial on the antidiabetic efficacy and safety profile of Saptavimshatika guggulu and Haridra churna in the management of type 2 diabetes mellitus. J Res Ayurvedic Sci 2021; 5:87-94.
- b. Mangal A, Jadhav AD, Ota S, et  al. Evaluation of Gokshuradi guggulu and Guduchi churna in the Management of Type II diabetes mellitus ( Madhumeha ). J Res Ayurvedic Sci 2019; 3(2):48-54.
- c. Srinivas  P,  Subhose  V,  Deep  VC,  Sharma  SK,  Ota  S,  Prasad  AJVS,  Babu  G, Radhakrishnan  P,  Sharma  OR,  Dua  P,  Rana  R,  Singhal  R,  Narayanam  S.  Clinical Evaluation  of Nisha  katakadikashaya and Yashada  bhasma in  the  Management  of Type-2  DM  ( Madhumeha )-  A  Multicentre,  Open  Label  Prospective  Study.  J  Res Ayurvedic Sci 2018; 2(2):108-121.
- d. Ota S, et.al. Clinical Safety of Selected Ayurvedic Formulations in Diabetes MellitusA  Pharmaco-epidemiological  Perspective.  J  Res  Ayurvedic  Sci  2018;  2(3):180-187.
- e. Shubhashree  MN,  Das  B,  Nanda  GC,  Swamy  GK,  Ota  S,  Doddamani  S,  Rao  MM, Tewari V, Sharma BS, Khanduri S, Rana R, Singhal R, Kumar A, Srikanth N. Efficacy and  safety  of Mamajjaka  ghanavati in  the  treatment  of  type  2  diabetes  mellitus:  A prospective open-label multicenter clinical study. Clin Trials Degener Dis 2019; 4:7-13

## B. Research studies on coded Ayurveda formulations (developed through rigorous R & D by CCRAS) for  Type II diabetes mellitus

## i. AYUSH 82

The  Council  has  developed  a  polyherbal  Ayurveda  formulation,  Ayush  82,  for managing  Type  II  diabetes  mellitus.  The  research  outcomes  are  published  in  peerreviewed  journals.  The  same  technology  has  been  transferred  to  11  Ayurveda manufacturing units through National Research Development Corporation (NRDC).

## ii. AYUSH D

The  Council  has  undertaken  scientific  validation  of  AYUSH -D,  a  polyherbal Ayurveda formulation, taking leads from LHTs through a systematic drug development  process . The  clinical  trial  of  Ayush  D  in  managing  Type  2 -diabetes mellitus as an add-on therapy to Metformin has been undertaken in collaboration with reputed institutes such as AIIMS, New Delhi, etc . The study has been completed, and the statistical analysis is being done .

## C. The  list  of  clinical  research  projects  on  Type  II  Diabetes  Mellitus  carried  out  is  as follows:

1. Clinical evaluation of Saptavimshatika guggulu and Haridra churna in the management of Type II diabetes mellitus
2. Clinical Evaluation of Nisha amalaki kashaya and Chandraprabha vati in the Management of Type II diabetes mellitus ( Madhumeha )
3. Clinical Evaluation of Nisha katakadi kashaya and Yashada bhasma in the Management of Type II diabetes mellitus ( Madhumeha )
4. Clinical  evaluation  of Gokshuradi  guggulu and Guduchi  churna in  the  management  of Madhumeha (Type II diabetes mellitus)
5. Clinical  Evaluation  of  the  Efficacy  and  Safety  of Mamajjaka  ghanavati in Madhumeha (Type 2 diabetes)
6. 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

## II. Central Council for Research in Homoeopathy (CCRH)

CCRH has implemented  the  Integration  of  Ayush  (Homeopathy  along  with  Yoga)  in  the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases & Stroke  (NPCDCS):  A  pilot  project  at  Krishna  District  (Andhra  Pradesh),  Darjeeling  (West Bengal)  covering  16  Community  Health  Centers/district  hospitals/area  hospital/block  primary health care centre. The program has been undertaken in collaboration with the Ministry of Health and Family Welfare under the NPCDCS programme.

Apart from this, various research studies have been done on diabetic mellitus, the results of which have been published in various journals, the details of which are as follows:

1. Sampath S,  Narasimhan  A,  Chinta  R,  Nair  KR,  Khurana  A,  Nayak  D,  et  al.  Effect  of homoeopathic  preparations of Syzygium  jambolanum and Cephalandra  indica on gastrocnemius  muscle  of  high  fat  and  high  fructose-induced  type-2  diabetic  rats. Homeopathy. 2013 Jul;102 (3):160-71.
2. Pal A, Misra BB, Das SS, Gauri SS, Patra M, Dey S. Antidiabetic effect of Cephalandra indica Q in diabetic rats. Indian J Res Homoeopathy 2013;7(2):81-90.
3. Maiti  S,  Bera  TK,  Chatterjee  K,  Ghosh  D.  Study  of  the  effect  of  mother  tincture  of Syzygiumjambolanum  on  metabolic  disorders  of  Streptozotocin  induced  diabetic  male albino rat. Indian J Res Homoeopathy 2014;8:129-35.
4. Rastogi DP., Saxena AC., Kumar S.Pancreatic beta-cell regeneration: a novel antidiabetic action of Cephalendra indica mother tincture.British Homoeopathic Journal 1988;  77(3): 147-151.
5. Nayak C, Oberai P, Varanasi R, Baig H, Ch R,  Reddy GR, Devi P et al. A prospective multi-centric open clinical trial of homoeopathy in diabetic distal symmetric polyneuropathy. Homoeopathy 2013;102(2):130-8.
6. Tiwari ML. Diabetes mellitus - defining the scope and clinical approach for homoeopathic management. Indian Journal of Research in Homœopathy 2008;2(3):28-36.
7. Nayak  C,    Singh  V,  Singh  K,  Singh  H,  Gupta  J,  Ali  Mohd.S,  et  al.    A  prospective observational study to ascertain the role of homœopathic therapy in the management of diabetic foot ulcer. American Journal of Homeopathic Medicine 2011; 104(4):166-76.
8. Baig  H,  Singh  K,  Sharma  A,  Kaushik  S,  Mishra  A,  and  Chug  S. Rhus  aromaticus in management  of  Diabetes  mellitus.  Clinical  Research  Studies-Series  II.  New  Delhi: CCRH; 2009:21-7.
9. Baig H, Singh K, Sharma A, Oberai P, Kaushik S, Nayak D, et al. Role of Cephalandra indica Q  in  the  management  of  diabetes  mellitus  as  an  add-on  medicine  along  with conventional antidiabetics. Indian Journal of Research in Homœopathy 2008; 2(3):22-7.
10. Baig H, et al. Management and homoeopathic treatment of peripheral vascular disease in relation to diabetes mellitus. CCRH Quarterly Bulletin1995;17(3-4):10-6.