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CTRI Number  CTRI/2024/12/077766 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To find whether taking turmeric extract for 12 weeks is good for people with knee joint pain. 
Scientific Title of Study   A randomized double-blinded placebo-controlled study to determine the efficacy of Turmeric extract (BCM-95) with mild to moderate osteoarthritis.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
AN-01BCM0824H4-WES23, Version 1.0 dated 20 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer  
Affiliation  Arjuna Natural Private Limited 
Address  Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.

Ernakulam
KERALA
683112
India 
Phone  09447818432  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer  
Affiliation  Arjuna Natural Private Limited 
Address  Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.

Ernakulam
KERALA
683112
India 
Phone  09447818432  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Dr Giby Abraham 
Designation  Senior Scientist Clinical Research 
Affiliation  Arjuna Natural Private Limited 
Address  Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O. Ernakulam

Ernakulam
KERALA
683112
India 
Phone  09995215790  
Fax    
Email  giby.a@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Pvt. Ltd. Desom Road, Aluva - 683102 
 
Primary Sponsor  
Name  Arjuna Natural Pvt Ltd 
Address  Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O., Ernakulam, Kerala. Pin - 683112 
Type of Sponsor  Other [Neutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhavanam Kishore  Amor Hospitals  Ground Floor, Department of Orthopedics, Near Balanagar Metro Station ‘Y’ Junction, Kukatpally Hyderabad
Hyderabad
TELANGANA 		 7569707316

dr.kishore.amorhospitals@gmail.com 
Dr Rakesh Komuravelli  Srikara Hospitals  Ground Floor, Department of Orthopedics, Near RTC X Road, Beside Nabard, Musheerabad, Zamistanpur, kavdiguda, Hyderabad
Hyderabad
TELANGANA 		 9866113630

dr.rakeshkomuravelli@gmail.com 
Dr Ram Kamal  Srikara Hospitals  Ground Floor, Department of Orthopedics, Plot no.50, LB Nagar, Hyderabad
Hyderabad
TELANGANA 		 8978696455

drramkamal.srikarahospitals@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Srikara Hospitals Ethics Committee  Approved 
Srikara Hospitals Ethics Committee  Approved 
Srikara Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  One capsule twice daily for 12 weeks 
Intervention  Turmeric extract (BCM-95) 200 mg  One capsule twice daily for 12 weeks 
Intervention  Turmeric extract(BCM-95) 200 mg  One capsule of Placebo in the morning and one capsule of Turmeric extract in the evening for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male or female 18 to 70 years of age with 1:1 ratio.
2. NRS score of ≥ 5 pain at the time of screening.
3. BMI 18 to 29kg/m2.
4. WOMAC score for Pain - 2 or more for any two activities. Stiffness – 1 or more for any
one activity. Physical function – sub-score 10 or more.
5. Doctor diagnosed OA of knee –with Kellgren–Lawrence classification grades 2-3.
6. Ability to follow all instructions in the study protocol and be willing to give written
informed consent.  
 
ExclusionCriteria 
Details  1. History of any underlying back pain, inflammatory arthropathy, rheumatoid arthritis, severe
osteoarthritis, fibromyalgia, gout or knee surgery within the past 6 months. Additionally,
include any anticipated surgeries in the next 4 months and details of any hyaluronic acid
treatments, either alone or in combination with Intra-articular corticosteroid injections
received within the past 3 months.
2. BMI ≥ 30.
3. Alcohol dependence
4. Smoking status more than 1 pack cigarettes per day.
5. Psychotic tendencies such as schizophrenia, taking any psychotropic medicines.
6. Psychedelic or narcotic substance use.
7. Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit
normal function in the judgment of the investigator.
8. History of the use ointments used for pain within the past 2 weeks, any antibiotics, NSAIDs,
steroids, over-the-counter pills as well as any supplements taken for joint pain three months
prior to your screening.
9. Any serious acute or chronic medical condition that in the judgment of the investigator would
make it inappropriate for the subject to participate in this study.
10. Positive pregnancy, breast feeding, pregnancy planning.
11. Subjects who have participated in a similar investigation in the past three months.
12. Unwilling to provide written informed consent.  
 
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 
Difference in the WOMAC recommended index of joint pain   Baseline, Week 6, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To assess OARSI performance-based tests  Baseline, Week 6, Week 12 
Change in NRS score  Baseline, Week 6, Week 12 
Change in anti-inflammatory and antioxidant biomarkers  Baseline, Week 6, Week 12 
To assess the safety by blood biochemistry, vitals  Baseline, Week 12 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   16/12/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Osteoarthritis (OA), a degenerative age-related disease that affects the joints, is the most common human musculoskeletal disorder and a leading cause of disability in elderly populations worldwide. The symptoms of OA include pain, morning stiffness, joint swelling, limited range of motion, decreased physical function, restriction of social activities and/or compromised work capacity. OA primarily affects articular cartilage and subchondral bone of synovial joints and results in joint failure, leading to pain with weight-bearing activities including walking and standing. Current OA treatments rely on analgesics, NSAIDs and cortisone, which manage pain and inflammation but have a wide range of adverse effects, drug interactions and contraindications and fail to restore the imbalances between catabolic and anabolic processes that underlie OA pathogenesis. This study aims to evaluate the efficacy of 200 mg of turmeric extract (BCM-95) can deliver clinically meaningful pain relief and functional improvement while maintaining a favorable safety profile.  
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