Management of Type 2 Diabetes Mellitus through Ayurveda

Recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/04/018494

Lead Sponsor: Jivanti Welfare and Charitable Trust

Brief Summary: Diabetes has been on the rise in India. There is now more than ever, a need to have a comprehensive cost-effective mass health care strategy to address the disease and its associated complication. Apart from the management of Diabetes, it also becomes vital to screen and identify the high-risk population and put in place appropriate interventions / strategies to prevent progression to diabetes mellitus.

VYASA is a yoga research foundation established in 1986 for education, research and propagation of all applications of Yoga with a vision to make Yoga a socially relevant science.

S-VYASA (a deemed University under section 3 of UGC act 1956), a NAAC A+ accredited University established in 2002 is an off shoot of VYASA.As a part of its mission, VYASA has scientifically validated Yoga practices and has been able to scientifically develop and administer personalised disease specific Yoga modules. In 2016, an initiative of VYASA was funded by the Ministry of AYUSH and conducted by IYA (Indian Yoga Association) as a nationwide randomised controlled research study of implementing Yoga based life style change program â€“ *Niyantritha Madhumeha Bharatha [NMB]* to treat and prevent incidence of Type 2 Diabetes mellitus.

Under the national scheme NMB, 2,40,968 adults were screened for Diabetes mellitus across the country in both urban and rural areas of India. Under the same scheme those diagnosed Type 2 Diabetes mellitus patients and those with high-risk were treated with Yoga and followed up for 3 months to understand the efficacy of Yoga.

In the present study we propose to study the efficacy of action of AYUSH-82 extract tablet in management of Type 2 Diabetes mellitus patients. Standardized ayurvedic formulation, AYUSH-82 extract tablet will be administered as intervention. The study is funded under the CSR (Corporate Social Responsibility) program of **Jivanti Welfare and Charitable Trust (JWCT)**.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 6000

Inclusion Criteria

With or Without hypertension and obesity With or Without Oral Hypo-glycaemic drugs [Any OHA] HbA1c >5.8%.

Exclusion Criteria

1.Type 2 Diabetes mellitus patients with major or minor cardiac, ophthalmic, renal complications.
2.Type 2 Diabetes mellitus patients with major neurological complications.
3.Type 2 Diabetes mellitus patients with associated conditions such as uncontrolled hypertension (persistent BP > 180/ 100 mm of Hg after two consecutive recordings and also by checking from their earlier medical records).
4.Type 2 Diabetes mellitus patients with severe obesity [BMI â‰¥ 40 kg/m2].
6.Type 2 Diabetes mellitus patients with history of tuberculosis within past 3 years.
7.Type 2 Diabetes mellitus patients with History of head injury, or psychiatric disorder in the past 8.Type 2 Diabetes mellitus patients in Pregnancy and lactation.
9.Type 2 Diabetes mellitus patients who are taking Homeopathy, Ayurveda, Unani & Siddha systems of medicine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FBS, HbA1C	0,3,6,12 Months

Secondary Outcome Measures

Name	Time	Method
Liver function test, Kidney Function Test, Lipid Profile	0,12 Months

Trial Locations

Locations (4): Bangalore
🇮🇳
Rural, KARNATAKA, India
Bhopal
🇮🇳
Bhopal, MADHYA PRADESH, India
Kalyan West
🇮🇳
Thane, MAHARASHTRA, India
Salem
🇮🇳
Salem, TAMIL NADU, India
Bangalore
🇮🇳Rural, KARNATAKA, India
Sreedhar P
Principal investigator
9632648161
YOGAATSREEDHAR@GMAIL.COM