| CTRI Number |
CTRI/2019/05/019212 [Registered on: 20/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To know the effect of i-CHARGE drink in improvement of physical energy and mental alertness |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRO-IND-001-19 Version 01,Date:02 Apr 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharath Kumar B |
| Designation |
Principal Investigator |
| Affiliation |
Kinesis Sports Clinic |
| Address |
Room number 01,1st floor,166, 4th cross Rd, JP nagar 4th phase,
Dollar Colony, Bengaluru,
Karnataka
Bangalore
KARNATAKA
560078
India |
| Phone |
8884244200 |
| Fax |
|
| Email |
sports.doctor.india@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi |
| Designation |
Medical Monitor |
| Affiliation |
In vitro Research solutions Pvt. Ltd, |
| Address |
Room Number 04,3rd floor, Clinical development department,#22&23 Kodigehalli Main Road, Sahakar Nagar, Hebbal, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
9900515364 |
| Fax |
|
| Email |
drpreethi@nextbio.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Bhaskar T |
| Designation |
Associate Director |
| Affiliation |
In vitro Research solutions Pvt. Ltd, |
| Address |
Room number 02,3rd floor,Clinical development department,#22&23, Kodigehalli Main Road, Sahakar Nagar, Hebbal, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
9741281900 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Indus Viva Health sciences Pvt Ltd
No 36, Viva Tower, Nandidurga Road,
Jayamahal Extn, Bangalore 560046.
|
|
|
Primary Sponsor
|
| Name |
Indus Viva Health sciences Pvt Ltd |
| Address |
No. 36, VIVA Tower, Deena Dayalu Naidu Road,Nandi Durga Road, Jayamahal Extn, Bangalore |
| Type of Sponsor |
Other [Neutraceuticals ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bharath Kumar B |
Kinesis Sports Clinic |
Room No:1, 1st floor
166, 16th Cross Rd, JP Nagar 4th Phase, Dollar colony, Phase 4, JP Nagar, Bengaluru, Karnataka 560078
Bangalore
KARNATAKA |
8884244200
sports.doctor.india@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifeline ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals who engages in regular physical workout |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i-CHARGE |
1 tin per day, before half an hour of workout |
| Comparator Agent |
placebo-controlled |
1 tin per day, before half an hour of workout |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
11.Subjects on appetite suppressants and or on medications to reduce weight |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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 placebo |
Day 15, Day 36 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
23/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blind
randomized single site two arm crossover placebo controlled
study Total
24 subjects will be
enrolled in the study out of which 12 subjects will be in test arm and 12 subjects will be in
Placebo arm The
primary objective of the study is 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 The secondary objective is comparison
of each of the acute effects such as endurance capacity physical energy and
mental alertness reduction of anxiety
between two study products Safety and tolerability of two study products Comparison
of carryover effect following intake of i CHARGE drink and placebo drink at
least three days after stopping intake of the study products Comparison of organoleptic
properties between i CHARGE drink and placebo |