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CTRI Number  CTRI/2022/06/043370 [Registered on: 20/06/2022] Trial Registered Prospectively
Last Modified On: 17/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study to measure the effect of natural product in muscle pain and related swelling and stress in healthy subjects. 
Scientific Title of Study   A randomized, double-blind, placebo controlled, clinical study to measure the effect of natural phytochemical formulation on muscle fatigue, endurance energy supply, recovery and neuro muscular activation in delayed onset muscle soreness (DOMS), and related inflammation and stress in healthy untrained subjects.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/22/002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. NA Ahmadabad GUJARAT 380 015 India

Ahmadabad
GUJARAT
380 015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. NA Ahmadabad GUJARAT 380 015 India


GUJARAT
380 015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft. Road, Satellite. NA Ahmadabad GUJARAT 380 015 India


GUJARAT
380 015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
AureaBiolabs Private Limited, XI/304A, Kadayiruppu, Kolenchery, Cochin, Kerala 
 
Primary Sponsor  
Name  AureaBiolabs Private Limited 
Address  XI/304A, Kadayiruppu, Kolenchery, Cochin, Kerala-682311  
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishal Sheth   Navneet memorial Hospital “Sushrusha”  Near Sardar Patel Samaj CG Road Opp. Navranpura telephone exchange, Navrangpura, Ahmedabad-380009, India.
Ahmadabad
GUJARAT 		 9925965133

drvaishalsheth@gmail.com 
Dr Akhil Mukim  Parikh Hospitals   Parikh Hospitals, police station, Sardar Patel Ring Rd, opp. Nikol, Nikol, Ahmedabad, Gujarat 382350
Ahmadabad
GUJARAT 		 9825074444

drakhilmukim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Riddhi Medical Nursing Home Institutional Ethics Committee for Parikh Hospital  Approved 
Riddhi Medical Nursing Home Institutional Ethics Committee for Sushrusha Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M798||Other specified soft tissue disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Single oral 500 mg dosage in capsule form, daily morning for 30 days after breakfast 
Intervention  Rephyll-(Natural Phytochemical Formulation)  Single oral 500 mg dosage in capsule form, daily morning for 30 days after breakfast. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Subject has provided written, signed and dated informed consent to
participate in the study.
2) Subject is willing and able to comply with the protocol,
3) Male or female subjects between 19-50 years of age (both inclusive).
4) Subjects should be untrained as defined by, less active that is regular exercise for less than 4 h per week.
5) Subject is in good health as determined by a health history and as per
Investigator discretion.
6) Subject is untrained in resistance/power exercise. 
 
ExclusionCriteria 
Details  1) Subject is participating in another clinical trial or has received an
investigational product within thirty days prior to enrollment.
2) Subject has a history of alcohol or other drug abuse in the past year.
3) Subject has a significant history or current presence of treated or
untreated bleeding disorder, diabetes mellitus, high blood pressure
(BP) [systolic BP> 140 and/or diastolic BP> 90], thyroid disease,
tachyarrhythmia, heart disease, kidney disease, or liver disease.
4) Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
5) Subject has a known allergy or sensitivity to any ingredient in the test product.
6) Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
7) Subject has a history of difficulty swallowing large pills or tablets.
8) Subject has used creatine within 9 weeks prior to screening.
9) Subject has a history of orthopedic injury or surgery within the last
year.
10) Subject has any physical condition considered a contraindication to the type of exercise performed in the study.
11) Subject has had an abnormal resting ECG.
12) Investigator is uncertain about subject’s capability or willingsness to comply with the protocol requirments. 
 
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 
1) Change in muscle fatigue
2) Change in endurance energy supply and recovery
3) Change in neuro muscular activation
4) Change in stress and anti-inflammatory biomarkers
5) Change in BP and pulse
6) Change in CBC and blood lipids
7) Subjective pain score: Subjective pain rating will be inspected utilizing a
numericalpain intensity scale. The visual assessment score (VAS) scale ranged from 0 (no pain at all) to 10 (extremely intense pain) 		 30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Type and incidence of adverse events.  30 days. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 04/07/2022 
Date of Study Completion (India) 12/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This clinical study will be conducted to measure the effect of natural phytochemical formulation on the muscle fatigue, endurance energy supply, recovery and neuro muscular activation in delayed muscle soreness (DOMS), and related inflammation and stress in healthy subjects. Total 110 subjects will be enrolled in the study.

All the subjects will be screened based on inclusion and exclusion criteria. Subjects who fulfilled the requirement will enrolled in the study. All the subjects will be followed up for day 4, 15, 30 and 60.The vitals and physical examination will be recorded during screening and also during all the visits in entire study. During randomization, performance of eccentric exercise, assessment of subjective painrating (NPRS), assessment of muscle fatigue with fatigue index will be measured. On respective visit, change in muscle fatigue, change in endurance energy supply and recovery, change in neuro muscular activation, change in stress and anti-inflammatory biomarkers, change in BP and pulse, change in CBC and blood lipids and measuring subjective pain score.


 
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