Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: null- Osteoarthritis Knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged between 35 and 65 years. 2. Patient of primary Osteoarthritis knee (Unilateral/ bilateral) as per at least three of following ACR clinical category of diagnostic criteria i.e.- i) crepitus on active motion, (ii) 3. Radio graphical changes as per Grade I to III of Kellgren & Lawrence Radiological scale. 4. Able and willing to participate and provide signed informed consent.
Exclusion criteria
Exclusion criteria: a. Patients with Grade IV Kellgren & Lawrence Radiological scale b. History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s). c. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis. d. Patients having any deformity of knee hip or back altering the gait and posture of the patient. e. Any unstable cardio-vascular diseases f. Patients with diabetes mellitus HbA1C > 6.5% g. Any other chronic systemic illness h. Patients with evidence of malignancy. i. History of knee arthroscopy/ knee replacement surgery j. Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab. value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]) k. The patient has been administered any chondoprotective drugs, intra-articular injection into the affected joint or systemic medication with corticosteroids during the preceding 3 months. l. Pregnant / lactating woman. m. Patient has an acute mental disorder n. Patients who are currently participating in any other clinical trial. Any other condition which the Principal Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total scoreTimepoint: 4th, 8th, 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Assessment of changes in Ayurvedic disease specific symptoms of sandhi vata [Time frame: at baseline and end of the 12th week] â?¢ Assessment of changes in subjects of different Prakritis using a specific questionnaire. â?¢ Assessment Quality of life by using WHOQOL BREF questionnaire [Time frame: at baseline,12th and end of the 16th week] â?¢ Use of analgesic in comparison to baseline (No. of times use of conventional analgesic drug). [Time frame: at baseline and 12th week] Timepoint: â?¢ Assessment of changes in Ayurvedic disease specific symptoms of sandhi vata [Time frame: at baseline and end of the 12th week] â?¢ Assessment of changes in subjects of different Prakritis using a specific questionnaire. â?¢ Assessment Quality of life by using WHOQOL BREF questionnaire [Time frame: at baseline,12th and end of the 16th week] â?¢ Use of analgesic in comparison to baseline (No. of times use of conventional analgesic drug). [Time frame: at baseline and 12th week] | — |
Countries
India
Contacts
Ayurveda central Research Institute