A clinical study to evaluate the efficacy and safety of Investigational Product on overweight subjects.
Not Applicable
Completed
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2020/03/024216
- Lead Sponsor
- GENECELL co ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Volunteers of either sex, between 18 to 60 years of age.
2. Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2
3. Subjects who agree the participation in the trial and submit informed and consent before the beginning of the trial
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically significant positive change from baseline to EOT (End of treatment) in the following efficacy parameters: <br/ ><br>1.Body fat rate by DEXA (Dual-energy X-ray absorptiometry) <br/ ><br>2.Body fat amount by DEXA (Dual-energy X-ray absorptiometry) <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Weight <br/ ><br>2.Waist Circumference <br/ ><br>3.Hip Circumference <br/ ><br>4.Waist to Hip Ratio <br/ ><br>5.Body Mass Index (BMI) <br/ ><br>6.Lean Mass by DEXA (Dual-energy X-ray absorptiometry) <br/ ><br>7.Total Cholesterol <br/ ><br>8.HDL-Cholesterol <br/ ><br>9.LDL-Cholesterol <br/ ><br>10.Triglyceride <br/ ><br>11.Visceral Fat Area <br/ ><br>12.Subcutaneous Fat Area <br/ ><br>13.Total Fat Area <br/ ><br>Timepoint: 12 weeks <br/ ><br>