A clinical study to assess the potential effect and safety of SUN-CA on the Risk Factors of Obesity
Phase 3
- Conditions
- Health Condition 1: null- Overweight or obese individuals with a BMI between 25-30 in the age group of 18-60 years
- Registration Number
- CTRI/2017/03/008170
- Lead Sponsor
- Vidya Herbs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Patients who are willing to give written informed consent.
2. Patient is willing and able to comply with all trial requirements
3.Overweight or obese; BMI between 25-30
Exclusion Criteria
• Subjects with BMI >30
• Cigarette smoker, History of heart, liver and kidney disease, hypertension, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reduction in body weight and BMI at week 4, 8 and 12 of treatment <br/ ><br> <br/ ><br>2. Muscle mass fat mass ratio, body fat (%) <br/ ><br>Timepoint: 1. Reduction in body weight and BMI at week 4, 8 and 12 of treatment <br/ ><br> <br/ ><br>2. Muscle mass fat mass ratio, body fat (%) <br/ ><br>at Day 1 and week 12
- Secondary Outcome Measures
Name Time Method 1. Changes in lipid profile (Triglycerides, cholesterol, HDL and LDL) <br/ ><br> <br/ ><br>2. Blood pressure <br/ ><br> <br/ ><br>3. Changes in anthropometric measurements â?? Waist and hip circumference; Waist-hip ratio <br/ ><br> <br/ ><br>4. Quality of life of subjects before and after treatment <br/ ><br> <br/ ><br>5. Incidence and rate of adverse events <br/ ><br> <br/ ><br>Timepoint: 12 weeks