Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
None listed
Sponsors
Mahatma Gandhi Ayurved College Hospital Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Individuals of any gender aged 50 to 70 years having diagnosed Knee osteoarthritis as per the ACR criteria, with the following parameters, will be included in the study: 1. Grade 1 to 3 radiographic changes in the affected knee (Kellgren-Lawrence classification) 2. Pain score of at least 2 (Numeric Pain rating scale) on most days of the last month 3. Able and willing to give signed informed consent ACR Criteria Pain in the knee and any three of the following: a. Age more than 50 years b. Less than 30 minutes of stiffness c. crepitus d. bony tenderness e. bony enlargement f. no palpable warmth
Exclusion criteria
Exclusion criteria: 1. History of knee joint replacement (on one or both knee joints) 2. History of intra-articular corticosteroids or hyaluronic acid administration or arthroscopy in the past six months 3. Currently taking or in the last three months taken anticoagulants or oral corticosteroids 4. History of significant trauma to the affected knee within the preceding one year 5. Diagnosed with Rheumatoid arthritis, Psoriatic arthritis, Lupus (SLE), Gout 6. BMI more than 30 kg/m 7. Currently suffering from or diagnosed with medical conditions, including but not limited to: Diabetes mellitus, Uncontrolled hypertension (more than 160/100 mm Hg), cardiovascular disease, neurological disease, psychiatric disorder, coagulation disorders, endocrine disease, or malignancies 8. Hepatic or renal function impairment (defined as AST and/or ALT more than three times the upper normal limit or serum Creatinine more than 1.2 mg/dL) 9. Currently suffering from or diagnosed with disease conditions that may interfere with the absorption of the trial intervention, such as gastrointestinal disease or GIT surgery 10. History of hypersensitivity to the trial intervention or its constituents 11. Currently taking or history of substance abuse/ alcoholism 12. Currently taking supplements that may affect the treatment outcome, such as chondroitin, glucosamine 13. Any other condition that, in the opinion of the investigator, may compromise the participant s safety or compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in knee pain score from baseline assessed through Knee Injury and Osteoarthritis Outcome Score (KOOS)Timepoint: Baseline, Day 14, 28, 42, and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the score for other symptoms of Primary Knee OA (stiffness, swelling, restricted range of motion, etc.), and function (ADL and recreational activities) assessed through KOOS 2. Change in the Numeric Pain rating scale score from baseline 3. Change in Pain Disability Index score from baseline 4. Change in the range of motion of the affected knee joint(s) from baseline (assessed through goniometer) 5. Change in knee OA-specific QoL from baseline assessed through KOOS QoL subscaleTimepoint: Baseline, Day 14, 28, 42, and 56;6. Change in the need of rescue analgesic medication from baseline (a diary will be maintained by the participant to record the intake of rescue medication if needed) 7. Incidence of Adverse events 8. Assessment of treatment adherence through self-reported compliance log and used medication containersTimepoint: Day 14, 28, 42, and 56;9. Change in laboratory safety parameters (LFT, KFT)Timepoint: Baseline, Day 56 | — |
Countries
India
Contacts
Public ContactDr Amit Kumar Rai
Mahatma Gandhi Ayurved College, Hospital & Research Centre
Outcome results
None listed