Dietary formulation for Diabetes
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/05/066629
- Lead Sponsor
- Dr.Swati Mohite
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Participants with Type 2 Diabetes mellitus on Oral Hypoglycemic Agents or insulin for at least 4 weeks that is not anticipated to change during the study.
Participants with Type 2 diabetes without medication
HbA1c = 6.5
Participants willing for inclusion in clinical trial.
Exclusion Criteria
Any neurological condition requiring urgent medical intervention.
Any other serious systemic disease in last 3 months.
Subjects having malignancies, serious infections as well as those requiring long term steroids and hormonal treatment.
Pregnant and lactating women.
Subjects having H/O renal transplant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Fasting & postprandial blood sugar level <br/ ><br> <br/ ><br> <br/ ><br>Reduction in HbA1c <br/ ><br>Timepoint: Baseline 30th and 60th <br/ ><br>
- Secondary Outcome Measures
Name Time Method Weight loss <br/ ><br> <br/ ><br>Reduction in abdominal, chest & hip circumference <br/ ><br>Timepoint: Baseline 30th 60th and 90th day