OPD-based trial for Treatment adherence, tolerability and safety of Ayurveda therapeutic regimen in the management of Primary Knee Osteoarthritis
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Pain in knee + Any three of the following
1. Age > 50 years
2. less than 30 minutes of stiffness
3. crepitus
4. bony tenderness
5. bony enlargement
6. no palpable warmth
1. Grade 3 and above radiographic changes in the affected knee (Kellgren-Lawrence classification) 2. Significant trauma to the knee including arthroscopy within preceding one year
3. History of knee joint replacement
4. BMI more than equal to 30 kg per m²
5 History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study
6. Patient taking corticosteroids
7. Patient with history of Rheumatoid arthritis Psoriatic arthritis Psoriatic arthritis or any other type of inflammatory arthritis
8. history of hepatic disorders (more than three times upper normal limit of normal of liver enzymes) or renal disorders (serum creatinine more than 1.2 mg%)
9. History or active malignancy
10. Hypersensitivity to study interventions
11. Any other disease condition that in the opinion of the investigator may compromise the participants safety or compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary <br/ ><br>1. Assessment of treatment adherence through self-reported compliance log and used medication containers/strips <br/ ><br>2. Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period <br/ ><br>3. Change in the laboratory safety parameters from baseline (CBC, LFT, KFT)Timepoint: 1. (Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>2. (Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>3. (Time frame: baseline, day 90, 180)
- Secondary Outcome Measures
Name Time Method 1. Change in WOMAC index score for pain, stiffness and physical function from baseline <br/ ><br>2. Change in the score of Numeric Pain rating scale from baseline <br/ ><br>3. Change in health related quality of life from baseline assessed through SF-12 questionnaire <br/ ><br>4. Change in the need of Rescue Analgesic medication <br/ ><br>Timepoint: 1. Time frame: day 30, 60, 90, 120, 150, 180 <br/ ><br>2. Time frame: day 30, 60, 90, 120, 150, 180 <br/ ><br>3. Time frame: day 30, 60, 90, 120, 150, 180 <br/ ><br>4. Time frame: day 30, 60, 90, 120, 150, 180