CTRI/2019/05/019212
Active, not recruiting
未知
A Double Blind, Randomized, Single Center, Two Arm, Two Sequence, Crossover, Placebo-Controlled Study to evaluate the safety and assess efficacy of i-CHARGE drink on mean improvement in endurance capacity, physical energy and mental alertness, after physical workout, and in reduction of anxiety in healthy adult subjects.
Indus Viva Health sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indus Viva Health sciences Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female aged more than or equal to 18 and less than or equal to 45 years of age
- •2\.Subject who engages in regular physical workouts
- •3\.Females of child\-bearing age should be willing to use standard methods of contraception
- •4\.Must be willing to give written informed consent and comply with the study procedures.
- •5\.Subjectâ??s complete blood count parameters and urine analysis to be within clinically acceptable range by Investigator
- •6\.Subject should be accessible on his/her cell phone
Exclusion Criteria
- •1\.Pregnant /lactating women and women who are planning to get pregnant, or less than six months post\-partum.
- •2\.Subjects with history of any substance use disorder including alcohol \& smoking.
- •3\.History of any uncontrolled and or unstable medical illness.
- •4\.Clinical history of allergy/ hypersensitivity to the study products.
- •5\.Recent (within last 3 months) participation in a clinical trial
- •6\.Subjects with unstable medical conditions
- •7\.Not willing to follow study restrictions
- •8\.Subjects otherwise judged by the investigator or sub \-investigator to be inappropriate for inclusion in the study.
- •9\.Subjects on immunosuppressantâ??s eg. Azathioprine, basiliximab, cyclosporine, daclizumab, corticosteroid and others.
- •10\.Subjects on sedative and CNS medications that cause sleepiness and drowsiness.
Outcomes
Primary Outcomes
Not specified
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