Ayurvedic approach to Prediabetes
Not Applicable
Completed
- Registration Number
- CTRI/2022/01/039395
- Lead Sponsor
- Dr Keertan M S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
1. Pre-diabetic subjects with HbA1c of 5.7-6.4%.
2. FBS <126mg/dl
3. Subject who submit a written informed consent
Exclusion Criteria
1. Known Cases of DM, both type I and II.
2.Past history of gestational diabetes
3.Uncontrolled Hypertensive subjects(with or without medication > 140/90 mmHg)
4.Pregnant / Lactating women.
5.Alcoholics and/or drug abusers
6.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuroendocrinal disorders, etc.)
7.Any other medical illness like Coronary Artery disease, Stroke etc
8.Patients who have completed participation in any other clinical trial during the past six (06) months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c level from baseline and in 90 daysTimepoint: 90 days
- Secondary Outcome Measures
Name Time Method 1.Changes in fasting insulin level from baseline and in 90 days <br/ ><br>2.Changes in Homa IR level from baseline and in 90 days <br/ ><br>3.Changes in fasting and Post prandial blood sugar from baseline and at 30th, 60th and 90th days <br/ ><br>4.Changes in lipid profile from baseline and at 90 days <br/ ><br>5.Changes in Liver function tests and Serum creatinine profiles from baseline and at 90 days <br/ ><br>6.Changes in BMI and waist circumference at baseline and at 30th , 60th and 90th days <br/ ><br>7.Changes in Quality of Life (DQoL): at baseline and at 30th, 60th and 90th days <br/ ><br>Timepoint: 30th, 60th and 90th days <br/ ><br>