A clinical study to assess the safety and efficacy of capsifen in a weight management study
- Registration Number
- CTRI/2018/04/013157
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1)Male or female healthy volunteers who have been practicing exercise or training
sessions for a minimum period of last 1 month to manage the obesity
2)Age 21-40 Years ( Both Inclusive)
3)Subjects with Body Mass Index (BMI) between 27Kg/m to 40 Kg/m
4)Shall agree to sign an Informed Consent Document
1)Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic, gastrointestinal problems, and renal problems
2)Subjects with a history of anorexia nevosa or other eating disorders
3)Subjects with known history of gastrointestinal irregularities
4)Prior use of anti obesity agents
5)History of surgical therapy for obesity
6)Subjects with known genetical syndromes which cause obesity
7)Subjects who are currently under any kind of long term medication
8)Subjects with a known allergy to herbal products
9)Subjects with abnormal biochemical or haematological values
10)Pregnant or Lactating Women
11)Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Energy Expenditure in comparison with baseline valuesTimepoint: Day 0, Day 56
- Secondary Outcome Measures
Name Time Method Change in Biochemical Markers in comparison with basline valuesTimepoint: Day 0, Day 56;Tolerabily, safety and adverse event assessmentTimepoint: Day 0, Day 28, Day 56