Health Condition 1: null- Osteoarthritis of Knee
Conditions
Interventions
Intervention1: LI73014F2 100mg: 1 capsule to be taken every
morning with breakfast and every night with dinner for 90 days
Intervention2: LI73014F2 200mg: 1 capsule to be taken every morning with brea
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory, male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2 • Unilateral or bilateral OA of the knee for greater than 6 months (ACR criteria) • Radiographic evidence (X-ray diagnosis) of OA during screening (IF subject has gone for X-Ray Diagnosis prior 15 days to screening ,that X-ray will be accepted as an evidence) • Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy • VAS score during the most painful knee movement between 40-70 mm • Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs • Results of screening are within normal range or considered not clinically significant by the Principal Investigator • Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial. • Willing to sign the informed consent and comply with study procedure
Exclusion criteria
Exclusion criteria: • Female subjects, who are pregnant, breast feeding or planning to become pregnant. • Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication • History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70) • Subjects scheduled for any surgery within 3 months of completing the study • Recent injury in the area affected by OA of the knee (past 4 months) • History of Gout • Have taken any corticosteroid, indomethacin, glucosamine+ chondroitin, within 3 months prior to the Treatment Period, Day0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period. • History of congestive heart failure • Subjects with HIV Positive • Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies • History of Systemic Lupus Erythematous (SLE) • High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) • History of psychiatric disorder that may impair the ability of subjects to provide written informed consent • Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit • Have taken acetaminophen / paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit (Visit 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from the baseline to the end of the trial period in WOMACTimepoint: Screening, Day 7,21,37,67 and 97 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from the baseline to the end of the trial period in VAS & LFITimepoint: Screening, Day 7,21,37,67 and 97;Mean Change in MMP-3, COMP and CP-II Serum BiomarkersTimepoint: Day 7 and Day 97 | — |
Countries
India
Contacts
Public ContactSanjib Kumar Panda
Laila Nutraceuticals
Outcome results
None listed