To know the effect of i-CHARGE drink in improvement of physical energy and mental alertness

Active, not recruiting

• Conditions: Healthy Individuals who engages in regular physical workout

• Registration Number: CTRI/2019/05/019212
• Lead Sponsor: Indus Viva Health sciences Pvt Ltd

Brief Summary

This is a double blindrandomized single site two arm crossover placebo controlledstudy Total24 subjects will beenrolled in the study out of which 12 subjects will be in test arm and 12 subjects will be inPlacebo arm Theprimary objective of the study is to assess mean improvement in endurancecapacity physical energy and mental alertness after physical workout and inreduction of anxiety following administration of study products The secondary objective is comparisonof each of the acute effects such as endurance capacity physical energy andmental alertness  reduction of anxietybetween two study products Safety and tolerability of two study products Comparisonof carryover effect following intake of i CHARGE drink and placebo drink atleast three days after stopping intake of the study products Comparison of organolepticproperties between i CHARGE drink and placebo

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 24

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.Subject’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 immunosuppressant’s eg.
• Azathioprine, basiliximab, cyclosporine, daclizumab, corticosteroid and others.
• 10.Subjects on sedative and CNS medications that cause sleepiness and drowsiness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess mean improvement in endurance capacity, physical energy and mental alertness after physical workout and in reduction of anxiety following administration of study products	Day 15, Day 36

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kinesis Sports Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Kinesis Sports Clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Bharath Kumar B

Principal investigator

8884244200

sports.doctor.india@gmail.com