EFFICACY OF BERBERINE ON GLYCAEMIC CONTROL IN PREDIABETIC INDIVIDUA
- Registration Number
- CTRI/2021/12/038751
- Lead Sponsor
- ANTARMAYEE PANIGRAHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. fulfilling prediabetic diagnostic criteria (taken within 12 weeks)
2. Agree to continue current diet and refrain from any new supplements
3. Able to read and understand English
4. Informed consent to the trial
5. Willingness to complete the Performa, drug diary and records associated with the study and cooperate for follow up calls and visits
1. Pregnant /lactating women / women planning for pregnancy in next 12 weeks
2. Transgender or individual on hormonal injection
3. Individual with co-morbidities like malnourishment, impaired hepatic and renal function, cardiac diseases, any acute/ severe diseases /undergone bariatric surgery
4. Currently on weight loss medications, any oral hypoglycaemic medication or insulin injection / steroids
5. Current daily use of herbal / non-herbal supplements
6. Current daily tobacco smoker /chewer / substance abuse
•Known allergies to the any substances of the product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Fasting Blood Glucose <br/ ><br>2.Fasting Insulin <br/ ><br>3.2hr Oral Glucose Tolerance Test <br/ ><br>4.Glycated Hemoglobin A1c <br/ ><br>5.Homeostatic Model Assessment For Insulin Resistance (HOMA-IR) <br/ ><br>Timepoint: 1. 1st follow-up: Day 28 ± 22. 2nd follow-up: Day 56 ± 2 <br/ ><br>3. End of the study visit: Day 84± 2 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Lipid profile : Total Cholesterol, Low Density Lipoprotein , High Density Lipoprotein <br/ ><br>2.Body weight and waist circumference <br/ ><br>3.BMI <br/ ><br>Timepoint: 1. 1st follow-up: Day 28 ± 2 <br/ ><br>2. 2nd follow-up: Day 56 ± 2 <br/ ><br>3. End of the study visit: Day 84± 2 <br/ ><br>