Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCE
Eligibility
Inclusion criteria
Inclusion criteria: Patient fulfilling the following- 1.American College of Rheumatology (ACR) functional status criteria class I, II and III (Pain in knee + Any three of the following: a. Age > 50 years b. less than 30 minutes of stiffness c. crepitus •bony tenderness •bony enlargement •no palpable warmth 2.Able and willing to give informed consent
Exclusion criteria
Exclusion criteria: 1.Grade 3 and above radiographic changes in the affected knee (Kellgren-Lawrence classification) 2.ignificant trauma to the knee including arthroscopy within preceding one year 3.History of knee joint replacement 4.BMI>=30 kg/m² 5.History of prior intra-articular corticosteroid or hyaluronic acid administration 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.Patients with uncontrolled Diabetes Mellitus (HbA1c >8.0). 9.History of hepatic disorders (more than three times upper normal limit of normal of liver enzymes) or renal disorders (serum creatinine > 1.2 mg %) 10.History or active malignancy 11.Hypersensitivity to study interventions 12.Any other disease condition that in the opinion of the investigator may compromise the participantâ??s safety or compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Assessment of treatment adherence through self-reported compliance log & used medication containers/strips â?¢Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events (GIT-related AE specifically) during the study period (Time frame: day 30, 60, 90, 120, 150, 180) â?¢Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: baseline, day 90, 180)Timepoint: Day 30, 60, 90, 120, 150, 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in WOMAC index score for pain, stiffness & physical function from baseline (Time frame: day 30, 60, 90, 120, 150, 180) â?¢ Change in the score of Numeric Pain rating scale from baseline(Time frame: day 30, 60, 90, 120, 150, 180) â?¢ Change in health related quality of life from baseline assessed through SF-12 questionnaire (Time frame: day 30, 60, 90, 120, 150, 180) â?¢ Change in the need of Rescue Analgesic medication (Time frame: day 30, 60, 90, 120, 150, 180)Timepoint: Day 30, 60, 90, 120, 150, 180 | — |
Countries
India
Contacts
Public ContactDr Amit Madan
Central Ayurveda Research Institute
Outcome results
None listed