None listed
Conditions
Interventions
Intervention1: i-CHARGE: Once in a day before physical workout
Intervention2: i-CHARGE: 1 tin per day, before half an hour of workout
Control Intervention1: placebo-controlled: 1 tin per day, before h
Sponsors
Indus Viva Health sciences Pvt Ltd
Eligibility
Inclusion 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
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. 11.Subjects on appetite suppressants and or on medications to reduce weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess mean improvement in endurance capacity, physical energy and mental alertness after physical workout and in reduction of anxiety following administration of study productsTimepoint: Day 15, Day 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Comparison of each of the acute effects endurance capacity, physical energy and mental alertness & reduction of anxiety between two study products 2.Safety and tolerability of two study products 3.Comparison of carry-over effect following intake of i- CHARGE drink and placebo drink at least three days after stopping intake of the study products 4.Comparison of organoleptic properties between i- CHARGE drink and placeboTimepoint: Day 15, Day 36 | — |
Countries
India
Contacts
Public ContactVijay Bhaskar T
In vitro Research solutions Pvt. Ltd,
Outcome results
None listed