Centre of excellence for research and clinical studies in Madhumeha (Diabetes mellitus)

Executive summary

Background

The Central Ayurveda Research Institute, Bengaluru is one of the peripheral Institutes of Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Govt. of India. The Institute established in 1971 has been engaged in Clinical Research, Drug standardization and Survey of Medicinal Plants in addition to providing healthcare facilities to the needy public. In recognition of its contribution in patient care and research, the Ministry of AYUSH, Govt. of India has awarded “Centre of excellence (CoE) for research and clinical services in Madhumeha (Diabetes mellitus)” in the year 2021 for a period of 4 years (3 years + 1 year extension).

Objectives

✅ Development of comprehensive document on “Ayurvedic guideline for prevention and management of diabetes mellitus”

✅ Validation of Ayurveda approaches for diabetes

✅ Validation of Ayurveda dietetics and development of ready to cook/ready to eat food for diabetes

✅ Prevention and management of diabetes mellitus with multi-specialty approach

✅ Developing technical collaboration with reputed organisations

✅ Capacity building for Ayurveda research in diabetes

✅ To obtain certification from National Accreditation Board for Hospitals & Healthcare Providers (NABH)

✅ To introduce e-healthcare initiatives (compliant with digital India) for prevention and management of Diabetes

Deliverables

Sl No.	Deliverables	Action Plan	1st Year	2nd Year	3rd Year	Outcome indicators
01	Preparation of “Ayurvedic guideline for prevention and management of Madhumeha (Diabetes mellitus) ”	• Drafting • Validation/ finalisation	Draft will be ready in first 6 months			• Publication of validated guideline
02	Validation of Ayurveda approaches for diabetes	A) Through planned clinical trials • Literature search and selection of intervention • Standardisation,preclinical safety toxicity, biological activity of selected formulations • Finalisation of protocol/documentation tools • Ethical committee approval / CTRI registration and initiation of trials B) Documentation of outcome of interventions used in routine OPD/IPD	Will be initiated in last 6 months			• Development of two formulations for diabetes • Documentation of at least 500 patients/ high-risk population Atleast two publications
03	Validation of Ayurveda dietetics and development of ready to cook/ready to eat food for Diabetes	• Literature search and selection of food recipes • Development of SOPs for preparation • Validation • Publication		Will be initiated in last 6 months		• Development of atleast two diet preparations for public use
04	Prevention and management of diabetes with multi-specialty approach	• Community IEC about diet, and lifestyle including yoga • Specialised training on Yoga / Ayurveda dietetics • Screening and management of high-risk population • Hospital based patient care • Referral of needy patients to Allopathy- integrated approach to follow • Documentation/ publication	Will be initiated during first 6 months			• Number of beneficiaries • Outcome of stand alone/ integrated interventions in patients/ high-risk population Upgradation of infrastructure
05	Networking – operational and technical collaboration	• Networking with local governance • With Central/ State Govt. local hospitals for referrals and integrated care • Tie up for specialised investigations like gut microbiome analysis / genetic marker study etc. • For drug standardisation and preclinical studies, preparation of sample medicines. For development of diet		last 6 months		• Effective collaborations happened • Successful completion of targets Management of referred cases
06	Capacity building for Ayurveda research in Diabetes	Training of human resources in research with special focus on diabetes		last 6 months		• Number of people trained • Number of people passing assessment parameters
07	NABH Accreditation	Upgradation of standards as per NABH guidelines to deliver quality healthcare		Will be initiated during first 6 months		• Obtaining NABH Accreditation certification
08	To introduce e-healthcare initiatives for prevention and management of Diabetes	Online appointment, telemedicine, e-records, digital IEC (literature, audio-visuals, SMS alerts etc.)				• Successful initiation of e-health programmes

Budget:
            Total sanctioned for three years.                 :₹ 7,24,80,400/-
            Budget released for the first year                : ₹ 2,88,00,000/-
            Budget released for second year (partial) : ₹ 20,00,000/-

Present status

✅ Ayurvedic guideline for prevention and management of Madhumeha (diabetes mellitus) is under validation.

✅ Exclusive OPD for screening/management of diabetes started to function on 22.07.2021 and has catered to 1838 diabetic patients and 5460 follow-up visits till February 2023. A total of 599 patients have been under Multi specialty care under CoE scheme.

✅ Free yoga classes are conducted in online and offline mode at CARI Hospital and in outreach camps and 332 patients have been benefitted.

✅ Risk assessment questionnaire developed, validated on 1000 subjects and a Diabetes predictive module has been developed using Machine learning and Artificial intelligence techniques in collaboration with experts from Centre for Incubation Innovation Research and Consultancy.

✅ 4 formulations shortlisted for validation of their anti-diabetic potential through literary search and expert opinion. Drug standardisation and quality control studies of the selected 4 formulations completed and pre-clinical efficacy studies are under progress.

✅ 51 Medical camps were conducted under CoE from time to time to screen patients for diabetes and diabetic-related issues, provide health-related education, doctor consultation, distribute medicines to treat diabetic and pre-diabetic problems and refer patients to the hospital for further follow-ups as needed, with the number of beneficiaries totalling to 1601.

✅ 10 Diabetes awareness talks for general public were conducted at various locations in Bengaluru with total beneficiaries being 391.

✅ 10 special training programmes were conducted for patients of Diabetes at CARI Hospital focussing on understanding Diabetes, Diet in Diabetes and Lifestyle modifications in Diabetes with total beneficiaries –193.

✅ 10 training programmes on Research methodology, Biostatistics, Chromatographic techniques and comprehensive management of Diabetes were conducted for Final year UG/First year PG students from different colleges of Karnataka with total number of trainees – 392.

✅ Thirteen Yoga training camps were held at various places around CARI Hospital with an intention to introduce Yoga and lifestyle changes in Diabetic and pre-diabetic populations.

✅ e-healthcare initiatives are carried out through the website www.cari.gov.in has reached out to over 26000 population.

✅ 5 Memorandums of Understanding have been signed under CoE with prestigious institutions like IISc Bengaluru for advanced research in Diabetes, Centre for Incubation Innovation Research and Consultancy for food technology, information technology & drug development, Nagpur Veterinary College for conduct of Pre-clinical safety/efficacy studies, Samatvam Science and Research for Human welfare Trust, Bengaluru for conduct of Clinical trials and CSIR-Central Food Technology Research Institute (CFTRI), Mysore for Diabetic diet research.

✅ 10 IEC materials developed with special focus on diabetes including Yoga interventions.

✅ NABH and NABL accreditation obtained to CARI hospital and CARI Clinical laboratory respectively.

✅ 6 articles published in peer reviewed journals and 5 accepted for publication.

✅ 7 small scale clinical studies taken up after IEC clearance and CTRI registration.

✅ Anti diabetic food preparation development underway in collaboration with reputed organisations viz. Centre for Incubation Innovation Research and Consultancy, Bengaluru and CSIR-Central Food Technology Research Institute (CFTRI), Mysore.