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CTRI Number  CTRI/2018/03/012367 [Registered on: 06/03/2018] Trial Registered Prospectively
Last Modified On: 13/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Benefits and harms of using moderately high dose Turmacin, an active ingrediant of turmeric on acute joint pain in healthy volunteers 
Scientific Title of Study   Tolerability and efficacy of moderately high dose Turmacin supplementation on joint discomfort among healthy volunteers – open label single arm pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajkumar S Amaravati 
Designation  Professor 
Affiliation  St. Johns Medical College 
Address  Department of Orthopaedics, St. Johns Medical College, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9945138739  
Fax    
Email  rajkumar_as@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jeffrey Pradeep Raj 
Designation  PG demonstrator 
Affiliation  St. Johns Medical College, Bangalore 
Address  Department of Pharmacology St. Johns Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8095464464  
Fax    
Email  jpraj.m07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeffrey Pradeep Raj 
Designation  PG demonstrator 
Affiliation  St. Johns Medical College 
Address  Department of Pharmacology St. Johns Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8095464464  
Fax    
Email  jpraj.m07@gmail.com  
 
Source of Monetary or Material Support  
Natural Remedies Private limited, Plot No. 5B, Veerasandra Indl. Area, 19th K. M. Stone, Hosur road, Electronic City Post, Bangalore, 560100.  
 
Primary Sponsor  
Name  Natural Remedies Private Limited 
Address  Plot No. 5B, Veerasandra Indl. Area, 19th K. M. Stone, Hosur road, Electronic City Post, Bangalore, 560100. 
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 Rajkumar S Amaravati  St. Johns Medical College  Sarjapura Road Bangalore
Bangalore
KARNATAKA 		 9945138739

rajkumar_as@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. Johns Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunteer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Turmacin 2g  Turmacin 2g capsule once daily orally for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All consenting adults aged between 18 and 65 years judged by Investigator to be in general good health on the basis of medical history
2.No knee joint discomfort/pain at rest;
3.Must achieve a knee joint discomfort/pain score of at least ≥ 40 mm on visual analogue scale (VAS) for pain after 10 minutes of brisk walk on the stepmill equipment.
 
 
ExclusionCriteria 
Details  1.Subjects having liver problems (raised ALT, AST), Heart (abnormal ECG / ECHO), kidney problems (raised creatinine), other muscle related problems (raised creatine kinase).
2.Subjects having neurological disorders
3.BMI greater than 32 kg/m2
4.Taking concomitant medication like pain relievers or complements/ multivitamin supplements/ phytotherapeutical products that interfere with the product or outcomes of the study.
5.Suffering from any kind of arthritic condition viz., autoimmune, infectious in the knee that could mislead the evaluation.
6.Having trauma or surgery histories that have affected the knee.
7.Having a disease that results in bad intestinal absorption
8.Women of child bearing age who do not wish to use approved birth control methods during study
9.Being pregnant or breastfeeding.
10.Allergic or hypersensitive to turmeric
11.Being participating or having participated in a clinical assay or intervention study within the previous 30 days before inclusion in the study
12.Being unable to follow the guidelines of the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
joint pain on visual analogue scale after exercise  days 5 and 7 
 
Secondary Outcome  
Outcome  TimePoints 
adverse effects  days 5 and 7 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/03/2018 
Date of Study Completion (India) 29/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Strenuous exercise in healthy individuals specifically sports person’s acts as a mechanical stressor on chondrocytes of knee, shifting the ECM balance towards catabolism. Animal study results with Turmacin, an active polysaccharide ingrediant from Turmeric,  have been promising in having an ameliorating effect on joint pain in osteoarthritis models. Hence the current clinical trial is proposed to understand the translational effects of animal study results in humans on acute pain and also to understand effect of moderately high dose Turmacin (2g/day) on joint discomfort in healthy individuals provided stress on the knee. 
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