Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Unani Formulation: Dosage Form: Majun (Electuary),
Dosage: 10 g/day (5 gm twice daily with water after meals),
Route of Administration: Oral,
Composition: 1. Suranjan Shirin (Merendr
Sponsors
National Research Institute of Unani Medicine for Skin Disorders.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of any gender aged 50-65 years 2. Clinical and Radiographic Knee Osteoarthritis as per the following ACR criteria: (a) Knee Pain (b) Osteophytes on Knee Radiograph, and (c) At least 1 of the following 3 criteria: i. Age >=50 years ii. Morning Stiffness lasting iii. Crepitus on Active Knee Motion 3. Knee OA of Kellgren-Lawrence Grade I to III 4. Body Mass Index (BMI): <40 Kg/m2
Exclusion criteria
Exclusion criteria: 1. Age less than 50 years and more than 65 years 2. Knee OA of Kellgren-Lawrence grade IV 3. BMI more or equal to 40 4. Patients with Knee Joint Effusion 5. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing spondylitis, psoriatic arthritis, gout), or any other type of arthritis 6. Patients on long-term steroid treatment 7. History of having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month 8. Any significant systemic diseases (hepatic, renal gastrointestinal, cardiovascular, neurologic or psychiatric disorder) and Diabetes Mellitus 9. History of Peptic Ulcer Disease & Bleeding Disorders 10. Known hypersensitivity to study drug or any of its ingredients 11. Pregnant and lactating women 12. History of addiction (alcohol, drugs) 13. Patients considered not eligible in the Investigatorâ??s opinion
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Systemic safety assessmentTimepoint: 6 Weeks | — |
Primary
| Measure | Time frame |
|---|---|
| 1. The decrease in severity of pain, stiffness and limitation of function of affected knee will be assessed by WOMAC OA Index. 2. The decrease in the severity of pain in affected knee will be assessed by 0-100 mm Visual Analog Scale (VAS) 3. Joint tenderness (pain on palpation) will be graded on a 4-Point Likert Scale (0-3) based on the patientâ??s response to palpation over the affected joint. 4. Patientâ??s Global Assessment of Response to Therapy (PGA) on a 5- point Likert Scale (0-4) 5. Investigatorâ??s Global Assessment of Response to Therapy (IGA) on a 5-point Likert Scale (0-4) 6. 50-Foot Walk Test (50-FWT) will also be used to study physical performance.Timepoint: 6 Weeks | — |
Countries
India
Contacts
Public ContactDr Haris Afzal
National Research Institute of Unani Medicine for Skin Disorders
Outcome results
None listed