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CTRI Number  CTRI/2016/12/007593 [Registered on: 19/12/2016] Trial Registered Prospectively
Last Modified On: 08/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   An open label, single-arm, multicentre study to evaluate safety and efficacy of Nutricharge Energy Drink in healthy human volunteers in India 
Scientific Title of Study   An open label, single-arm, multicentre study to evaluate safety and efficacy of Nutricharge Energy Drink in healthy human volunteers in India  
Trial Acronym  Nutricharg Energy Drink  
Secondary IDs if Any  
Secondary ID  Identifier 
TW/NED/013/16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Arvind Sakhi 
Designation  Director 
Affiliation  Trophic Wellness Private Limited 
Address  Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra, India.
Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra,
Mumbai
MAHARASHTRA
400067
India 
Phone  022-28680353  
Fax    
Email  arvind@nutricharge.in  
 
Details of Contact Person
Scientific Query  
Name  Mr Arvind Sakhi 
Designation  Director 
Affiliation  Trophic Wellness Private Limited 
Address  Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra, India.
Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra,
Mumbai
MAHARASHTRA
400067
India 
Phone  022-28680353  
Fax    
Email  arvind@nutricharge.in  
 
Details of Contact Person
Public Query  
Name  Mr Arvind Sakhi 
Designation  Director 
Affiliation  Trophic Wellness Private Limited 
Address  Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra, India.
Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra,
Mumbai
MAHARASHTRA
400067
India 
Phone  022-28680353  
Fax    
Email  arvind@nutricharge.in  
 
Source of Monetary or Material Support  
Trophic Wellness Private Limited 142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra, India.  
 
Primary Sponsor  
Name  Trophic Wellness Private Limited 
Address  142 AB Kandivali Industrial Estate, Kandivali west, Mumbai-400067, Maharashtra, India.  
Type of Sponsor  Other [industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jignesh Shah  Het Medical Hospital  Bhairavnath Cross Road, Bhairvanath Rd, Navrang Society, Maninagar, Ahmedabad
Ahmadabad
GUJARAT 		 9904333669

drjignesh81@gmail.com 
Dr Nirmal Parmar  Prisha Medical Care  Shop No.19, 2nd Floor,Nakshatra Avenue, Opp. Manikrupa School, IOC Road, Chandkheda, Ahmedabad
Ahmadabad
GUJARAT 		 9924493190

dr_nirmal82@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Care Institute of Medical Sciences  Approved 
Ethics Committee of Care Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nutricharge(R) Energy Drink  Subjects should consume the Nutricharge Energy drink orally after lunch between 3-3.30 p.m. daily for 10 days. [1 pack (200ml) in a day].  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  a) Age group: 18 years - 40 years
b) Subjects in good physical condition and sound mental status.
c) In the judgment of the Principal Investigator, able to comply with protocol requirements.
d) Subjects passing all the screening tests
e) Subjects willing to sign written informed consent
 
 
ExclusionCriteria 
Details  a) Pre Diabetic & Diabetic Subjects
b) Pre-hypertensive & Hypertensive subjects
c) Subjects addicted to alcohol, Drugs of Abuse or tobacco
d) Hypersensitivity to study product or any contents of the energy drink
e) Presence of any major illness such as cancer, heart disease, COPD, Asthma etc.
f) Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past
g) Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study
h) Current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
i) Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
j) Subjects with acute illness or history of major or minor surgery in the past one year.
k) Female subjects who are currently pregnant and/or breast feeding
l) Subjects receiving any medical therapy for any illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measures: Safety
 		 Day 0 to Day 10
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures: Efficacy  Day 0 to Day 10 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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   Phase 3 
Date of First Enrollment (India)   21/12/2016 
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)  Other (Terminated) 
Publication Details   Not yet this stage 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is an open label, single arm, multicenter clinical study to evaluate efficacy and safety of Nutrichargeâ Energy Drink in healthy subjects.
A total of up to 115 healthy adults will be enrolled to get 100 completed subjects in to the study.
The study is a multi-center study with up to 3 sites participating in the study. 
Test Product: Nutrichargeâ Energy Drink, Trophic Wellness Pvt. Ltd.
Test product is required to be consumed orally after lunch between  3–3.30 pm once daily for 10 days.
Pack Size: 200 ml – Tetra pack (1 Pack a day)
 

 
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