Health Condition 1: null- Patient with knee Osteoarthritis
Conditions
Interventions
Intervention1: OLNP-08 500 mg - BID for 60 days: One capsule of 500mg Twice daily
Intervention2: OLNP-08 500 mg OD for 60 days: One capsule of 500mg OLNP-08 and one placebo capsule of 500mg Placebo T
Sponsors
Olene Life sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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. Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria) 3.Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3 4. 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 year or had a hysterectomy and/or bilateral oophorectomy 5. VAS score during the most painful knee movement between 40-70 mm 6. Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs 7. Results of screening are within normal range or considered not clinically significant by the Principal Investigator 8. Be willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application(OTC or prescription) and Omega 3 fatty acids during the entire trial. 9. Willing to sign the informed consent and comply with study procedure
Exclusion criteria
Exclusion criteria: 1. Female subjects, who are pregnant, breast feeding or planning to become pregnant. 2. 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 3. History of underlying inflammatory arthropathy or severe RA or OA 4. Subjects scheduled for any surgery within 3 months of completing the study 5. Recent injury in the area affected by OA of the knee (past 4 months) 6. History of Gout 7. History of congestive heart failure 8. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies 9. History of Systemic Lupus Erythematosus (SLE) 10.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc) 11. History 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline in WOMAC ScoreTimepoint: Day 0, Day 7, Day 15, Day 30, day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in â?¢ Visual Analog Scale & â?¢ Lequesneâ??s functional index (LFI) â?¢ Primary knee flexion Timepoint: Day 0, Day 7, Day 15, Day 30, day 60 | — |
Countries
India
Contacts
Public ContactNilima
Olene Life Sciences Private Limited
Outcome results
None listed