A Randomized, Double-blind, Placebo-Controlled trial to Assess the Efficacy and Tolerability of UC-II® in Modulating Knee Joint Functio
- Conditions
- Health Condition 1: null- Osteoarthritis of the knee
- Registration Number
- CTRI/2013/02/003348
- Lead Sponsor
- InterHealth Nutraceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
1.Ambulatory, male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
2.Female subjects of childbearing potential must agree to use a medically acceptable form of birth control throughout the duration of the study (e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier) and have a negative pregnancy test at all study visits. Female subjects of non childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
3.Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria) and Kellgren and Lawrence radiographic grading of grade 2 or 3
4.VAS score during the most painful knee movement between 40-70 mm after 7 days withdrawal of excluded medications.
5.Lequesneâ??s functional index score between 6-10 points after 7 days withdrawal of excluded medications.
6.Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator.
7.Be willing and able to participate in all scheduled visits, dosing plan, tests and other trial procedures according to the clinical protocol.
8.Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
9.Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
1.History of hypersensitivity to NSAIDS, or any other similar pharmacological agents or components of the products.
2.History of hypersensitivity to eggs, chicken/fowl, or shellfish.
3.History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70).
4.Hyperuricemia ( >440 µmol/L) and/or past history of gout.
5.Expectation of surgery in the next 4 months.
6.Recent injury in the area affected by OA of the knee (past 4 months).
7.Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 1 (Visit 2) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period. (A 2-week washout period is allowed for subjects taking omega-3 fatty acid supplements)
8.History of congestive heart failure.
9.Anticipated problems with product consumption.
10.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years
11.History of Systemic Lupus Erythematosus (SLE).
12.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc).
13.Females who are pregnant or lactating or planning to become pregnant.
14.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
15.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit (Visit 1).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the change in the overall WOMAC score from baselineTimepoint: Screening, Day 1, 7, 30, 60, 90, 120, 150 and 180
- Secondary Outcome Measures
Name Time Method Change from baseline in Knee flexion range of motionTimepoint: Day1,Day7,Day30,Day60,Day90,Day120,Day150 and Day180;Change from baseline in LFI ScoreTimepoint: Day1,Day7,Day30,Day60,Day90,Day120,Day150 and Day180;Change from baseline in Serum biomarker, COMP & CRPTimepoint: Day 1, Day 60 and Day 180;Change from baseline in Synovial biomarkers, IL-6 & MMP-3Timepoint: Day 1 and Day 180;Change from baseline in VAS scoreTimepoint: Day1,Day7,Day30,Day60,Day90,Day120,Day150 and Day180;Mean change in WOMAC subscale (pain, stiffness and physical function)Timepoint: Day1,Day7,Day30,Day60,Day90,Day120,Day150 and Day180