Effect of turmeric extract Capsules in subjects with mild to moderate Osteoarthritis of Knee

Phase 3

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2023/07/055411
• Lead Sponsor: utriventia Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female subjects 45 – 75 years of age with a Body Mass Index (BMI) of approximately 18 to 29 kg/m2.

2. Unilateral or bilateral OA of the knee for greater than 3 months NICE criteria and radiographic evidence by Kellgren - Lawrence grade 2 or 3 (Knee X-ray assessment done for OA within 1-month prior to randomization can be considered and the test might not be repeated)

3. VAS score during the most painful knee movement between 40-70 mm. According to the criteria from NICE, patients can be diagnosed with knee OA if they are 45 years or older, have movement-related joint pain and either no morning knee joint related stiffness or stiffness that lasts no longer than 30 min.

4. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.

5. Results of screening tests are within normal range or considered not clinically significant by the Principal Investigator.

6. Otherwise, healthy subjects as determined by: Medical history, Physical examination, and clinical judgment of Principal investigator.

7. Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) and / or any other pain reliever including topical application (OTC or prescription), any herbal or Ayurvedic or nutraceutical supplement during the entire trial.

8. Willing to provide voluntary consent by signing the informed consent form and comply with study procedures

Exclusion Criteria

1. Subjects younger than 45 years or older than 75 years

2. Female subjects, who are pregnant, breast feeding or planning to become pregnant.

3. Subjects who underwent treatment for COVID 19 within last 3 months or tested positive during the study.

4. Subject with known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication.

5. History or presence of underlying inflammatory arthropathy, RA, severe OA, gout, Systemic Lupus Erythematosus (SLE) or any other systemic disorder affecting joints.

6. Subjects scheduled for surgery within 3 months of completing the study.

7. Recent injury in the area affected by OA of the knee (past 4 months)

8. History or presence of congestive heart failure

9. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies

10. History of High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)

11. History or presence of psychiatric disorder that may impair the ability of subjects to provide written informed consent.

12. Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit

13. Have taken any corticosteroid, indomethacin, Glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pain score on Visual Analogue Scale (VAS) [100 mm] between test & placebo from baseline to end of the treatmentTimepoint: Baseline (Day 1) & End of Study- Day 90

Secondary Outcome Measures

Name	Time	Method
Change in Pain score on Visual Analogue Scale (VAS) [100 mm]Timepoint: Baseline (Day 1) to Day 3, Day 07, Day 15, Day 30, Day 45, Day 60 & Day 90.;Inflammatory Markers - TNF- a, CRP, IL – 6 & IL-1ßTimepoint: Baseline (Day 1) to Day 45, & Day 90;KOOS (Knee Injury & Osteoarthritis Outcome Score)Timepoint: Baseline (Day 1) to Day 3, Day 07, Day 15, Day 30, Day 45, Day 60 & Day 90.