FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/068070 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study to evaluate the Efficacy and Safety of a Dose for Soreness in reducing Muscle Soreness and improving muscle relaxation  
Scientific Title of Study   A Randomized, Placebo-Controlled, Double-Blind Clinical Study to evaluate the Efficacy and Safety of a Dose for Soreness (Dietary supplement) in reducing Muscle Soreness and improving muscle relaxation in Healthy adults 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
DO/DFS/23 Dated 10-March -2024, Version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Mishra MD(General Medicine) 
Designation  Consultant - Physician 
Affiliation  Shivnath Hospital 
Address  Room no 2. Ground floor, Shivnath Hospital, Ledhupur, Varanasi, Uttar Pradesh
Ledhupur, Varanasi, Uttar Pradesh, 221007
Varanasi
UTTAR PRADESH
221007
India 
Phone  6202223524  
Fax    
Email  deepakmishra1979@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ghanashyam Patel MD Ayu 
Designation  Head- Scientisit  
Affiliation  GREEN MEDIC SOLUTION 
Address  Office No 19, 3rd Floor, Samanvay Status-2, Atladara-Padra Main Road

Vadodara
GUJARAT
390012
India 
Phone  9824654050  
Fax    
Email  patel.drg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkateshwarlu K  
Designation  Head - Clinical Operations 
Affiliation  Ayurlife Health Solutions 
Address  Department of Clinical Operations, Ground Floor, Room #1, #10/1, 13th Main Road, Srinagar

Bangalore
KARNATAKA
560050
India 
Phone  9945232107  
Fax    
Email  drvenkatesh64@gmail.com  
 
Source of Monetary or Material Support  
Eetho Brands Inc.4210, Del Rey Ave #409 Marina Del Rey, CA 90292 
 
Primary Sponsor  
Name  Eetho Brands 
Address  4210, Del Rey Ave #409 Marina Del Rey, CA 90292  
Type of Sponsor  Other [Nutraceutical industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Mishra  Shivnath Hospital  Room no 2, Ground floor, Ashapur,Ledhupur,sarnath,varnasi-221005
Varanasi
UTTAR PRADESH 		 6202223524

deepakmishra1979@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Shivanath Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Subjects 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Placebo Subjects will be administered with the 60 ml of Liquid (shot) orally for 30 days twice daily.
2Intervention ArmDrugOther than Classical(1) Medicine Name: Dose for Soreness, Reference: NA, Route: Oral, Dosage Form: Dravaka, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water, if required), Additional Information: Subjects will be administered with the 60 ml of Liquid (shot) twice daily.
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male or female subjects between 19 to 60 years of age
2. Adult subjects with good health, as determined by a health history and at the Investigators discretion.
3. Subject willing to participate and able to comply with the protocol.
4. Subjects who provide written, signed, and dated informed consent.
 
 
ExclusionCriteria 
Details  1. Subjects with a sleep disorder or a history of clinical depression, eating disorders, or other psychiatric conditions.
2. Subjects with a history or current presence of health conditions, including abnormal resting ECG, bleeding disorder, diabetes, high blood pressure, thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
3. Participants using medications - anti-inflammatory, analgesic, antioxidant drugs, nutritional products, and dietary supplements that may interfere with the study results, as determined by the investigators opinion.
4. History of allergy or sensitivity to any ingredient in the test product, as well as a history of alcohol or other drug abuse within the last year.
5. Participation in another clinical study within the past 30 days.
6. Subjects with a history of orthopaedic injury or surgery within the last year.
7. Presence of any physical condition considered a contraindication to the type of exercise to be performed in the study.
8. Subjects who do not agree to participate or are not capable of complying with protocol requirements.
9. Women who are pregnant or breastfeeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to end of the trial period in Improvement in the stabilization of muscles or a reduction in the degree of muscle fatigue measured by an increase in VO2 max (treadmill)  Baseline (Day 0), Day 15 and Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to end of the trial period in Decrease in levels of Creatine Kinase (CK) assessed by the oxidative stress and inflammatory marker test (Hs CRP)   Baseline (Day 0), Day 15 and Day 30 
Change from baseline to end of the trial period in Reduction in pain score, identified using the Visual Analog Scale (VAS).   Baseline (Day 0), Day 15 and Day 30 
Change from baseline to end of the trial period in Global assessment of overall improvement from baseline to end of the study (SGA and PGA)  Baseline (Day 0), Day 15 and Day 30 
Change in the levels of C-reactive protein from baseline to end of the study  Baseline (Day 0), Day 15 and Day 30 
Change in vital sign parameters from baseline to end of the study  Baseline (Day 0), Day 15 and Day 30 
Change in laboratory safety parameters (haematological parameters, liver function, kidney function and blood lipid profile parameters) from baseline to end of the study.  Screening and EOT 
Incidence of adverse events during study period  Day 15 and Day 30 
SF 36 – QOL – Vitality scale  Baseline (Day 0), Day 15 and Day 30 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/06/2024 
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="6"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Randomized, Placebo-Controlled, Double-Blind Clinical Study to evaluate the Efficacy and Safety of a Dose for Soreness (Dietary supplement) in reducing the Muscle Soreness and improving the muscle relaxation in Healthy adults. subjects shall be administered with either test product or Placebo daily twice for 30 days.  

 
Close