Health Condition 1: null- Osteoarthritis of Knee
Conditions
Interventions
Intervention1: LI15903F1: 1 capsules to be taken every
morning with breakfast and every night with dinner for 30 days
Intervention2: LI15903F1 350mg: one capsule every monring with breakfast and every
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 3 months (ACR criteria) • Subjects with radio graphic evidence by Kellgren - Lawrence grade 1 to grade 2 • 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 Acetaminophen / 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, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period. History of congestive heart failure 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 and 37 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from the baseline to the end of the trial period in VAS & LFITimepoint: Screening, Day 7,21 and 37 | — |
Countries
India
Contacts
Public ContactSanjib Kumar Panda
Laila Nutraceuticals
Outcome results
None listed