None listed
Conditions
Interventions
Intervention1: LI13019F1: Dose: 2 Capsule twice daily (each capsule contains 100 mg of novel herbal formulation LI13019F1).
Frequency: BD,
Duration: 60 Days,
Route of Administration: Oral.
Control Int
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory, male and female subjects 30 â?? 65 years of age with a Body Mass Index (BMI) of approximately 18 to 29.9 kg/m2. • Only nonâ??osteoarthritic subjects with radio graphic evidence by Kellgren - Lawrence grade 0. • 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. • Results of screening should be within normal range or considered not clinically significant by the Principal Investigator. • Subjects having mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest. • 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, 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 or 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 30 days 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in 80 meter Fast-Paced walk testTimepoint: Day 1, Day 7, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement from baseline to end of the trial period in : â?¢ 30 sec Chair Stand Test â?¢ VAS â?¢ WOMAC A (Pain), WOMAC B (Stiffness) and WOMAC C (Physical function) scores â?¢ Primary Knee flexion range of motion. Endpoints for Safety â?¢ Adverse events (AEs), frequency and severity. â?¢ Proportion of subjects who discontinue study treatment due to adverse events. â?¢ Changes in vital parameters.Timepoint: Day 1, Day 7, Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactShekhar Gupta
Laila Nutraceuticals
Outcome results
None listed