Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of either gender between 30 and 70 years of age. 2. Patients presenting with chronic knee joint pain and stiffness of at least 3 months duration, aggravated by walking, bending or occupational activity, with radiological evidence of knee joint degeneration on X-ray knee Grade 1 and Grade 2.
Exclusion criteria
Exclusion criteria: 1. Individuals with recent knee fractures, ligament injuries or other acute knee trauma requiring immediate surgical intervention. 2. Individuals with severe autoimmune disorders such as systemic lupus erythematosus or advanced rheumatoid arthritis with organ involvement, or advanced renal, hepatic or cardiac failure. 3. Participants with uncontrolled hypertension, diabetes mellitus, or major liver or kidney disorders. 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in knee joint pain, stiffness and physical function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Timepoint: Baseline, Week 4, Week 8, Week 12 and Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in knee joint pain intensity measured using the Visual Analogue Scale (VAS)Timepoint: Baseline, Week 4, Week 8, Week 12 and Week 16;Change in knee joint range of motion assessed by goniometryTimepoint: Baseline, Week 4, Week 8, Week 12 and Week 16;Change in inflammatory markers Erythrocyte Sedimentation Rate (ESR) and C reactive Protein (CRP)Timepoint: Baseline and Week 12;Safety and tolerability assessed by monitoring of adverse events and laboratory parameters including Complete Blood Count, Liver Function Tests and Kidney Function TestsTimepoint: Baseline and Week 12 | — |
Countries
India
Contacts
Parul Institute of Ayurveda, Parul University