A pilot study on the effects of comprehensive Ayurveda intervention in participants with prediabetes.
Phase 2
- Conditions
- Health Condition 1: Z682- Body mass index (BMI) 20-29, adult
- Registration Number
- CTRI/2023/11/060199
- Lead Sponsor
- Center for Integrative Medicine & Research, All India Institute of Medical Sciences, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Fulfill prediabetes diagnostic criteria [FPG (110-125 mg/dl) and / or OGTT (140-200 mg/dl)]
2.Capable and willing of giving signed consent form
Exclusion Criteria
1.Patients with H/o prior use of medication to treat diabetes/ prediabetes in last 3 months.
2.Currently using oral hypoglycemic agents
3.Decompensated cardiac, kidney, hepatic failure, endocrine disorder.
4.Pregnant and lactating females.
•Who have participated in any other interventional study in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Reversal of prediabetes to normoglycemic state at 12 weeks. <br/ ><br>(The reversal of prediabetes will be determined by FPG 110mg/dl and 140 mg/dl of 2 hour- OGTT test.) <br/ ><br>Timepoint: Baseline, 12 weeks
- Secondary Outcome Measures
Name Time Method •Mean change in 2-hour OGTT at 12 weeks. <br/ ><br>•Mean change in FPG and HbA1c at 12 weeks <br/ ><br>•Mean change in homeostasis model assessment of Insulin resistance (HOMA-IR), Insulinogenic index and Disposition index at 12 weeks <br/ ><br>•Mean change in BMI at 12 weeks <br/ ><br>•Mean change in Quality of life (SF-36) at 12 weeks <br/ ><br>Timepoint: Baseline, 12 weeks