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CTRI Number  CTRI/2023/09/058104 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Activity of Curcumin derivative on Joint Inflammation (knees) of the patients.  
Scientific Title of Study   Double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of C3 Reduct in patients with Joint Inflammation of the knees. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh G 
Designation  Principal Investigator 
Affiliation  NRR Hospital 
Address  3&3A Hesaraghatta Road, Chikkabanavara, near to chikkabanavara railway station, Bangalore
3&3A Hesaraghatta Road, Chikkabanavara, near to chikkabanavara railway station, Bangalore
Bangalore
KARNATAKA
560090
India 
Phone  07022247227  
Fax    
Email  drmaheshg98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.
Bangalore
KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.

KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@clinworld.net  
 
Source of Monetary or Material Support  
Sami Sabinsa Group Limited 
 
Primary Sponsor  
Name  Sam Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh G  NRR Hospital  3&3A Hesaraghatta Road, Chikkabanavara, near to chikkabanavara railway station, Bangalore
Bangalore
KARNATAKA 		 07022247227

drmaheshg98@gmail.com 
Dr Girish H R  Rajalakshmi Hospital  #21/1 Lakshmipura Main Road, Vidyaranyapura Post, Bengaluru.
Bangalore
KARNATAKA 		 09845516613

girirudra@yahoo.co.in 
DrMadhavanJeyaraman  SriLalithambigaiMedical College& Hospital  SriLalithambigaiMedical College& HospitalServiceRd,MaduravoyalAdalampattu,ChennaiTamilNadu60095
Chennai
TAMIL NADU 		 04429577777

madhanjeyaraman@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Independent Ethics Committee- CLINISYD Research Global Solutions Private Limited  Approved 
Institutional Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M129||Arthropathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C3 Reduct  It is combination of curcumin derivatives of 70 mg capsule to be administered twice a day after breakfast and dinner for 90 days. 
Comparator Agent  Placebo  Capsule containing microcrystalline cellulose- 70mg to be administered twice a day after breakfast and dinner for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and Female participants whose age ≥18 and ≤ 60 years.
2. Participants should provide a written and signed informed consent and comply with requirements of the study.
3. HsCRP level should be equal or more than 3 mg/dl.
4. Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications.
5. Patients with the pain perception ranging from 30 to 100 when measuring VAS (Visual Analog Scale) of 0- 100mm.
6. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol. 
 
ExclusionCriteria 
Details  1. Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infections.
2. Patients with history of knee and hip replacement surgery.
3. Treatment of knee joint pain with intra-articular injections of corticosteroids within last 3 months preceding study.
4. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
5. Patients with history of asthma or on medication with Ipratropium Bromide.
6. Patients undergoing treatment for any systemic illness.
7. Pregnant, lactating women or women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study.
8. History of chronic smoking and alcoholics.
9. Those who have participated in any other clinical trial within the last 3months from the date of first visit.
10. Any other condition/ reason which the principal investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale.
2. Mean change in the VAS 		 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale from day-1 to day 90.
2. Mean change in the VAS from screening to day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean change in the HsCRP, IL-6 & ESR.
2. Mean change in the range of Movement by Goniometer.
3. Safety as determined through changes in the lab results and incidence of adverse events during the study period in both arms. 		 1. Screening to Day-90
2. Screening to Day-90
3. Screening to Day-90 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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/ Phase 4 
Date of First Enrollment (India)   14/10/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  		 The study involves 96 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either C3 reduct-70mg (Arm-1) or Placebo (Microcrystalline cellulose-70) Arm-2. Specific biomarkers such as IL-6, HsCRP, lipid Profile will be measured and analysed during the study period. Goniometer and scales such as modified WOMAC and KOOS will be also analysed during the study period. The final statistical analysis and study report will be complied at the end of the study period. 
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