Treatment for knee joint Osteo Arthritis in Ayurveda

Phase 4

Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: M170- Bilateral primary osteoarthritis of knee

Recruitment & Eligibility

Inclusion Criteria

1 American College of Rheumatology (ACR) functional status criteria class I, II and III

2 Able and willing to give informed consent

Exclusion Criteria

EXCLUSION CRITERIA

Patients with the following criteria will be excluded from the study:

Grade 3 and above radiographic changes in the affected knee (Kellgren-Lawrence classification)

Significant trauma to the knee including arthroscopy within preceding one year

History of knee joint replacement

BMI>=30 kg/mÂ²

History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study

Patient taking corticosteroids

Patient with history of Rheumatoid arthritis, Psoriatic arthritis, Psoriatic arthritis, or any other type of inflammatory arthritis

History of hepatic disorders (more than three times upper normal limit of normal of liver enzymes) or renal disorders (serum creatinine > 1.2 mg%)

History or active malignancy

Hypersensitivity to study interventions

Any other disease condition that in the opinion of the investigator may compromise the participantâ??s safety or compliance

Primary Outcome Measures

Name	Time	Method
1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips <br/ ><br>2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) <br/ ><br>3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week <br/ ><br>Timepoint: 1Assessment of treatment adherence through self-reported compliance log and used medication containers/strips <br/ ><br>2Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: at 4 week, 8 week, 12 week, 16 week, 20 week, 24 week) <br/ ><br>3Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: at baseline, 12 week, 24 week <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1 Change in WOMAC index score for pain, stiffness & physical function from baseline (Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>2 Change in the score of Numeric Pain rating scale from baseline(Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>3 Change in health related quality of life from baseline assessed through SF-12 questionnaire (Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>4 Change in the need of Rescue Analgesic medication (Time frame: day 30, 60, 90, 120, 150, 180) <br/ ><br>Timepoint: 30,60,90,120,150,180 days