A clinical study to evaluate the glycemic index (glucose level in blood in 2 Hour period) and safety of COCOZEN in Human Volunteers.
- Registration Number
- CTRI/2018/03/012389
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1)Males and females in the age 18 â?? 55 years
2)Normal physical condition as determined by the investigator
3)Subject with body mass index 18.5- 27 Kg/m2 (Both inclusive)
4)Must be willing to comply with all study requirement
5)Subject should agree to avoid any kind of herbal formulations during the study period
6)Must be able and willing to provide a written informed consent.
1)Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic and renal problems
2)Subjects who are currently under any kind of long term medication
3)Subjects with a known allergy to herbal products
4)Chronic drinkers
5)Subject with a habit of smoking
6)Subjects with abnormal biochemical or haematological values
7)Subjects with abnormal blood pressure
8)Pregnant or Lactating Women
9)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 Safety and tolerability assessment of COCOZEN by the measurement of hematological and Biochemical ParametersTimepoint: Day 0, Day 90
- Secondary Outcome Measures
Name Time Method Glycemic index of COCOZENTimepoint: Day 0, Day 2, Day 4,Day 6