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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 6 years (3 years + 3 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 4th Year 5th 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 1st draft is ready for review Draft under review Guideline is ready, yet to be Published • 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 Done Done Validation of 200 patients Under progress • 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 Initiated with clinical trial Clinical Trial completed Extended clinical trial on ready to cook recipe will be initiated • 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 Complete Complete On going • 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 Complete Complete On going • 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 347 patients and 490 students were oriented. 397 patients and 547 students were oriented. • 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 Done Done • 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.) More than 5,00,000 population benefited On going • 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 the Second year. : ₹ 2,76,46,200/-
  • Budget released for the Third year. : ₹ 1,58,34,200/-

Present status

  • Development of comprehensive document on Diabetes entitled “Reimagining Diabetes Care through the Lens of Ayurveda: An Integrated Framework for the Prevention and Management of madhumeha (Diabetes)” yet to publish.
  • Exclusive OPD for screening/management of diabetes started to function on 22.07.2021 and has catered to catered to 4,718 diabetic patients and 24,696 follow-up visits offering Ayurveda treatment totalling up to 29,414 visits.
  • 8,937 patients have had free laboratory investigations under the scheme.
  • Free yoga classes were conducted at CARI Hospital and 1240 (for both OPD and IPD) patients have been benefitted.
  • 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. Copy right form is received for the same and risk assessment portal is developed and made available in the institute website for the viewers to assess the risk of Diabetes.
  • Clinical trials for 2 selected anti-diabetic formulation completed.
  • Clinical trial to evaluate two ready to cook dietary supplements for its antidiabetic property in patients of type-2 diabetes mellitus is completed and taken up for extended clinical study.
  • 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 2516.
  • 10 Diabetes awareness talks for general public were conducted at various locations in Bengaluru with total beneficiaries being 748
  • 20 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 –629
  • 30 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 –1463.
  • 26 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 5,00,000 population.
  • Total population coverage under e-healthcare initiatives is 4,11,802.
  • 6 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 , CSIR-Central Food Technology Research Institute (CFTRI), Mysore for Diabetic diet research and Government Ayurveda Research Centre, Mysore for collaboration on academic programmes, research partnerships, and training.
  • 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.
  • 16 articles published in peer reviewed journals, 2 accepted for publication and 4 Under review.
  • 12 clinical studies, 1 pre clinical study and 1 case series have taken up after IEC clearance and CTRI registration and all the trials are completed.
  • 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.
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