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CTRI Number  CTRI/2025/09/095478 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check how well the test product help in relieving muscle tiredness 
Scientific Title of Study   A prospective, open label, comparative, case study to evaluate the efficacy and safety of immediate release bioenhanced curcuminoids (Zing95) in muscle soreness. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CMS-10-25, Version: 1.0, Dated: 28-08-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R M Muthiah MBBS MD 
Designation  Critical Care Physician 
Affiliation  Ki3 PRIVATE LIMITED 
Address  Oxymed Hospital Medical and Healthcare Center, No 14 1,2nd street, 3rd Main Road, Nandanam, Chennai

Chennai
TAMIL NADU
600035
India 
Phone  9994399111  
Fax    
Email  muthsmail@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan 
Designation  Consultant and CI 
Affiliation  Ki3 PRIVATE LIMITED 
Address  Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai- 600044
Chennai
TAMIL NADU
600032
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Director 
Affiliation  Ki3 PRIVATE LIMITED 
Address  Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai- 600044
Chennai
TAMIL NADU
600032
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
MAKAMS Industries Private Limited, F-12, ADARSHINI PLAZA, 91, ADCHINI, SRI AUROBINDO MARG, , NEW DELHI,Delhi, India - 110017  
 
Primary Sponsor  
Name  MAKAMS Industries Private Limited 
Address  F-12, ADARSHINI PLAZA, 91, ADCHINI, SRI AUROBINDO MARG, , NEW DELHI,Delhi, India - 110017 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  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 R M Muthiah MBBS MD  Oxymed Hospital and research institute  Consultation room no: 1,Critical Care Physician, No 14/1,2nd street, 3rd Main Road, Nandanam, Chennai 600 035
Chennai
TAMIL NADU 		 9994399111

muthsmail@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oxymed Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M791||Myalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Curcumin 95% - 500 mg  One capsule orally, once daily after 1 hour of exercise, for 7 days. 
Intervention  Immediate Release Curcuminoids - Zing 95 -200 mg of 95% Curcuminoid   One capsule orally, once daily after 1 hour of exercise, for 7 days. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Healthy human volunteers aged between 21 years to 35 years
2. The study will include trained candidates who have not performed any exercise in the last 2 months.
3. Participants with no known musculoskeletal pathology
4. Participants willing to sign informed consent and to undergo all the study procedure.
 
 
ExclusionCriteria 
Details  1. Participants using systemic corticosteroids within 2 months of screening
2. Participants with any other investigational drug within 1 month prior to randomization;
3. Participants with uncontrolled diabetes mellitus and hypertension
4. Participants with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure
5. Pregnant and lactating women
6. Participants with significant abnormal laboratory parameters
7. Known hypersensitivity to any of the ingredients of test product
8. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The change in muscle pain on VAS
The change in muscle tenderness by VAS tenderness on palpation
Assessment of change in muscle swelling
Assessment of change in jump performance
Power output
To evaluate the reduction in tiredness and fatigue measured with Chalder Fatigue Scale
Assessment of Delayed Onset Muscle Soreness will be conducted
To measure change in Lean Body Mass (LBM) and Muscle Mass by CULT Smart Scale PRO  		 Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of change in Creatinine Kinase ,CRP , LDH after 1 hours of exercise.
To evaluate the improvement in energy levels by measuring VO2 max through Downhill Treadmill test
Assessment of endurance by 6 Minute Walk Test will be conducted
Assessment of requirement of Paracetamol or NSAIDs as rescue medicine
The overall change in condition will be assessed on Day 7 using a 5-point Likert-type scale by both the investigator & the participant.
Assessment of tolerability of study product by investigator & participant.
Adverse events assessment  		 Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) & Day 7. 
 
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   Phase 3 
Date of First Enrollment (India)   10/10/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 study will enroll 24 healthy volunteers aged 21–35 years who engage in moderate physical activity and develop muscle soreness after gym-based exercise. Eligible participants will be trained individuals who have not exercised in the past two months and have no musculoskeletal pathology. The study will evaluate the efficacy and safety of Zing95 curcuminoids through multiple parameters, including changes in muscle pain, tenderness, swelling, jump performance, fatigue, lean body mass, creatine kinase, CRP, LDH, VO 2 max, and endurance. Assessments will be conducted from baseline through Day 7, with additional evaluation of paracetamol or NSAID use, tolerability, satisfaction, and adverse events. 
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