None listed
Conditions
Interventions
Intervention1: LI15906F6 250mg: 1 capsule to be taken every morning before breakfast and night before dinner for 90 days
Intervention2: LI15906F6 400mg: 1 capsule to be taken every morning before brea
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Ambulatory, male and female subjects 35 â?? 70 years of age with a Body Mass Index (BMI) of approximately 18 to 29 kg/m2 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 Subjects having mild-to-moderate pain in knee joint upon completion of 6 Minute walk test (6MWT) or Stair climb test (SCT), and otherwise no knee pain at rest Subjects with radio graphic evidence by Kellgren - Lawrence grade 0 Results of screening should be 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: Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear. History of underlying inflammatory arthropathy or severe RA or OA. Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation. Expectation of surgery during the study duration period. Female subjects, who are pregnant, breast feeding or planning to become pregnant. Subject having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol 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 or any vascular conditions. Subjects with HIV Positive status Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 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 |
|---|---|
| Improvement from baseline to end of the trial period in : 6 Minute walk test (6MWT) Timepoint: Day 0,7,21,37,67 and 97 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement from baseline to end of the trial period in : Stair Climb Test (SCT) VAS WOMAC A (Pain) subscale WOMAC B (Stiffness) and WOMAC C (Physical function) subscales Primary Knee flexion range of motion Physician Global Assessment (PGA) Timepoint: Day 0, 7, 21, 37, 67 and 97 | — |
Countries
India
Contacts
Public ContactPrason Kumar
Laila Nutraceuticals
Outcome results
None listed