Siddha Intervention for Osteoarthritis
Phase 2
Suspended
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of knee
- Registration Number
- CTRI/2019/04/018752
- Lead Sponsor
- Central Council for Research in Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Sex – Both sex
2. Patients with Primary Osteoarthritis - knee joints (single or both knees).
3. Swelling in the Knee Joints
4. Joint stiffness
5. Restricted movements of joints.
6. Crepitus of joints.
7.Patients with WOMAC Score = 25 = 72
Exclusion Criteria
1.Age less than 40 years or more than 60 years.
2.Patients with Diabetes/Hepatic failure/Renal failure.
3.History of bony or soft tissue injury to knee joint/ surgical interventions
4.Patients having Rheumatoid arthritis, Gout, Viral fever (Chikungunya) and Psoriatic arthritis.
5.Patients who are taking any form of steroids.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Safety of the study drug will be assessed by using following parameters: CBC, HB, PCV, LFT, RFT, Diabetic profile, Lipid profile and Urine routine on 0 day and 31st day. <br/ ><br>2.Efficacy of the trial drug will be assessed by WOMAC 3.1 INDEX on 0 day, 31st day and 90th day.Timepoint: 0 day - Before inclusion of Trial . <br/ ><br>31st day - After Successful completion of Trial. <br/ ><br>90th day - Trial Follow-up <br/ ><br>
- Secondary Outcome Measures
Name Time Method Improvement in the quality of life of AKV patients will be evaluated through OAKHQOL index on 0 day, 31st day and 90th day.Timepoint: 0 day - Before inclusion of Trial . <br/ ><br>31st day - After Successful completion of Trial. <br/ ><br>90th day - Trial Follow-up