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CTRI Number  CTRI/2025/02/081342 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   This is a clinical trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in participants with osteoarthritis of knee joints. 
Scientific Title of Study   An Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with osteoarthritis of knee joints. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
OKJ/CT/2025, Version No. 1.0 , Dated 13-Jan-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh Bansal 
Designation  Principal Investigator 
Affiliation  Panchsheel Hospitals Pvt. Ltd. 
Address  C-3/63A, 64A, opp. Gokulpuri police station, Block C, Yamuna Vihar, Delhi-110053

North East
DELHI
110053
India 
Phone  981055884  
Fax  -  
Email  bansal.pkw@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lokesh Bansal 
Designation  Principal Investigator 
Affiliation  Panchsheel Hospitals Pvt. Ltd. 
Address  C-3/63A, 64A, opp. Gokulpuri police station, Block C, Yamuna Vihar, Delhi-110053

North East
DELHI
110053
India 
Phone  981055884  
Fax  -  
Email  bansal.pkw@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Kumar 
Designation  Director-Clinical Trial Operations  
Affiliation  IR Innovate Research Pvt Ltd 
Address  Building No.-C-120,3rd Floor, Gautam Buddha Nagar UTTAR PRADESH 201301 India UTTAR PRADESH 201301 India Gautam Buddha Nagar UTTAR PRADESH

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9971169602  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Source of Monetary or Material Support  
Sunpure Extracts Private Limited,Sunpure House Plot No. 11/29, Sahibabad Industrial Area, Sahibabad, Ghaziabad, UP - 201010, INDIA 
 
Primary Sponsor  
Name  Sunpure Extracts Private Limited 
Address  Sunpure House Plot No. 11/29, Sahibabad Industrial Area, Sahibabad, Ghaziabad, UP - 201010, INDIA  
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 Lokesh Bansal  Panchsheel Hospitals Pvt. Ltd.  Clinical Research Room, Room No.-B-1,C-3/63A, 64A, opp. Gokulpuri police station, Block C, Yamuna Vihar, Delhi-110053
East
DELHI 		 981055884

bansal.pkw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CurcuBoost®   1 capsule (500mg) to be taken along with standard of care once daily, orally with plain for 56 +/- 2 days or 8 weeks. 
Comparator Agent  Standard of Care  Subjects in comparator arm will receive allowed Standard of Care as per protocol and in judgment of Investigator for 56 +/- 2 days or 8 Weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  To participate in the study, subjects must meet the following criteria:

1. Signed Patient Information Sheet and Informed Consent Form to participate in the
study.
2. Men and women aged 40 to 75 years (inclusive)

3. Diagnosis of osteoarthritis of the knee joint established in accordance with the
classification criteria of the American College of Rheumatology (ACR) and with X-ray
signs of grade II or III according to the Kellgren-Lawrence classification.

4. Pain during walking in target knee joint according to VAS greater than 40 mm (moderate or
severe pain when walking).

Patients with bilateral osteoarthritis of knee joints can be included in the study, but data on efficacy and safety must be collected for the most painful knee joint (target knee). According to VAS, the level of pain in the contralateral knee joint must be less than in the target knee joint (less than 40 mm), if the pain intensity is the same in both joints, joint with a higher grade according to Kellgren-Lawrence classification is chosen. If both knee joints are equally painful and have the same stage according to the Kellgren-Lawrence classification, then the knee joint is chosen at the discretion of the investigator.

5. Need of daily/ long-term use of NSAIDs (at least 30 days) over the past three months.

6. Consent of patients, including men and women with childbearing potential (who have not undergone surgical sterilization or who have been in menopause less than 2 years), to use adequate contraception methods during the entire study and 3 months after the end of therapy. Adequate contraceptive methods include a condom or diaphragm (barrier method) with a spermicide.
 
 
ExclusionCriteria 
Details  A subject will be considered unsuitable for the study if they meet any one of the following criteria:

1. Concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis etc.)

2. Significant (requiring surgical treatment) valgus or varus deformity of the knee joint, ligamentous laxity, or destruction of the meniscus.

3. Concomitant osteoarthritis of the hip and/or ankle joints, of severe grade, which may make it difficult to assess the effectiveness or pain in the knee joint.

4. History of septic arthritis of any joint or suspected subacute infectious inflammation in the target joint.

5. Surgical treatment of a targeted knee in history.

6. Planned surgery on any joint of the lower extremities during the study.

7. Lymphovenous insufficiency of the lower limbs, grade III.

8. Diseases and concomitant conditions affecting the structure and density of bone tissue (hyperparathyroid osteodystrophy, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.).

9. Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure greater than 180 mm Hg and diastolic blood pressure greater than 110 mm Hg, pulmonary embolism or deep vein thrombosis.

10. Subjects with BMI greater than equal to 40 kg/m2

11. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.

12. Diseases manifested by increased bleeding (hemorrhagic diathesis, hemophilia, thrombocytopenia, etc.), or conditions with a high risk of bleeding.

13. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.

14. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.

15. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.

16. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).

17. Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.

18. Pregnant or lactating women or women planning a pregnancy during the clinical study.

19. Hypersensitivity to any of the components of the investigational product in medical history.

20. Prior therapy with the following drugs:

• Administration of systemic glucocorticoids within 2 months prior to screening.
• Intra-articular administration of any medicinal products within 4 weeks prior to screening.
• Administration of oral slow-acting products, including dietary supplements for the treatment of osteoarthritis of the knee joint (chondroitin sulfate, glucosamine sulfate, Piascledine, Diacerein) within 3 months prior to screening.
• Administration of bisphosphonates, strontium ranelate, hormone replacement therapy, parathyroid hormone preparations, preparations of monoclonal antibodies to RANKL, active metabolites of vitamin D within 12 months prior to screening.
• Administration of other products that can affect the metabolism of bone tissue (antiepileptic preparations, anabolic steroids, etc.) 4 weeks prior to screening.

21. Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of CurcuBoost® therapy in standard regimen based on
change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in
patients with osteoarthritis of knee joints in Indian population.
 		 To determine the efficacy of CurcuBoost® therapy in standard regimen based on
change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in
patients with osteoarthritis of knee joints in Indian population.
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoint is to evaluate theChange in WOMAC scores (pain, stiffness, function).
• Efficacy evaluation based on OMERACT-OARSI responder criteria (in
correspondence to T. Pham 2004).
• Change in the score according to the EQ-5D Health Questionnaire.
• Change in the score according to the Patient’s Global Assessment scale.
• Change in the score according to the Investigator’s Global Assessment scale.
• Change in the score according to the Patient’s Global Pain Assessment according to
VAS scale.
• Incidence of adverse events (AE) of various severities and serious adverse events
(SAE) on the basis of subjects’ complaints. 		 Baseline/Randomization, Day 28(Week 4) & Day 56 (Week
8) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   08/03/2025 
Date of Study Completion (India) 03/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

It is an Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with osteoarthritis of knee joints.

OA(Osteoarthritis) is currently considered as a disease caused by dynamic reaction of joint to a variety of biomechanical and biochemical factors. It occurs when degradation of cartilage exceeds repair. The ligaments surrounding the joint become lax, joint capsule thickens, joint fluid becomes less viscous, muscle undergo wasting and become weak. Cartilage has no pain sensation. Pain in OA arises from bone and other structures within and around the joint. Crystals and swelling inside the joint are important causes of pain in OA.

CurcuBoost® employs advanced formulation technology to enhance curcumin’s bioavailability, potentially amplifying its therapeutic benefits in OA management. Administering CurcuBoost® alongside SOC treatments could provide a synergistic effect, improving pain relief, joint function, and overall patient outcomes while minimizing reliance on high-dose NSAIDs and associated adverse events.

 
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