Efficacy of Ayurveda therapies on Diabetes biomarkers

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2023/09/057404
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients diagnosed with Diabetes Mellitus according to WHO criteria

Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 372016

Recently diagnosed patients who are not on OHA both overweight and obese and normal BMI ICMR criteria

Subjects of either gender aged more than 18 years.

Fasting blood sugar more than 126 mgperdl to 250 mgperdl

Patients with random blood sugar level more than 200 mgperdl to 450 mgperdl

Postprandial blood sugar more than 200 mgperdl to 450 mgperdl

Glycosylated Haemoglobin more than 6.5 to 15

Exclusion Criteria

Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin-dependent.

Patient with inflammatory bowel disease chronic diarrhoea or malabsorption; Hepatitis etc.

Patient with a history of other complications with DM.

Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication;

Patients reporting to be hypersensitive to any of the proposed trial drug.

Currently under any other trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood sugar fasting & post prandial & HbA1C. (in mg/dl) <br/ ><br>Sr. Insulin, LDL-cholesterol & triglycerides <br/ ><br>Biomarkers such as, <br/ ><br>Apolipoprotein A1, <br/ ><br>Adiponectin <br/ ><br>hs-CRP <br/ ><br>Body weight & Hip-waist circumferenceTimepoint: Baseline, day 30, Day 60, Day 90 and Day 120

Secondary Outcome Measures

Name	Time	Method
Quality of Life in DM by QOLID <br/ ><br>Ayurveda parameters such as Roga & Rogi Bala <br/ ><br>Timepoint: Quality of life assessment specific to Diabetes Mellitus will be assessed at the beginning day 0 & end of therapy day 90 <br/ ><br>Roga and Rogi bala will be assessed at the beginning day 0 and end of therapy day 90 <br/ ><br>