This is a single center study wherein the efficacy of Sabeet® in cardiovascular and exercise performance will be studied in 20 adult male healthy volunteers in comparison to Placebo using a crossover design.
- Registration Number
- CTRI/2015/11/006387
- Lead Sponsor
- Sami labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1 Male healthy adult subjects ranging in age from 18 to 55 years (both inclusive) normotensive, physically active but not exercise trained.
2 Willingness to follow the protocol requirements as evidenced by written, informed consent.
3 Agree not to use any medication (prescription and over the counter), including vitamins and
minerals, during or before the course of this study.
4 Subjects whose blood chemistries are within a normal range or not considered clinically
significant if outside the normal range.
5 Non-smokers and non-alcoholics.
6 Willing to come for all follow-up visits.
1 Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
2 Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate, temperature) haematology, serum chemistry.
3 History of hypersensitivity reactions.
4 Participation in a clinical study during the preceding 90 days.
5 Any contraindication to blood sampling.
6 Blood or blood products donated in past 30 days prior to study supplement administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method