Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
CCRAS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Participant of any gender in the age group 40-65 yrs of Scheduled Caste community 2. Participant who are willing to provide written consent. 3. Participant of primary Osteoarthritis knee (Unilateral/ bilateral) as per any one of the following three ACR diagnostic criteria 1. Using history and physical examination Pain in the Knee and 3 of the following: i. Over 50 years of age. ii. iii. Crepitus on active motion iv. Bony tenderness v. Bony enlargement vi. No palpable warmth 2. Using radiographic findings: (if available) Pain in the Knee and 1 of the following: i. Over 50 years of age. ii. iii. Crepitus on active motion and osteophytes. 3. Using history, physical examination and laboratory findings: (if available) Pain in the Knee and 5 of the following: i. Over 50 years of age. ii. iii. Crepitus on active motion iv. Bony tenderness v. Bony enlargement vi. No palpable warmth of synovium vii. ESR viii. Rheumatoid Factor (RF) ix. Synovial fluid (SF) signs of osteoarthritis
Exclusion criteria
Exclusion criteria: i. Diagnosed cases of Rheumatoid arthritis or other type of inflammatory arthritis or patients who report to have been under anti-arthritic medication for RA or inflammatory arthritis. ii. Participant prescribed Joint replacement surgery. iii. Participant with history of trauma to the afflicted joint. iv. Use of ambulatory aids such as wheel chair, walker etc v. Someone who has BMI>=32kg/m² at the screening visit. vi. Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. vii. Known case of Renal/ Hepatic / Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, Uncontrolled DM or HTN. viii. Pregnant women/ women who are planning for conception and lactating women ix. Patient taking participation in any other clinical trial. x. Any other condition which the P.I. thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified â??CRD Pune Version)Timepoint: i. Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified â??CRD Pune Version) | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Change in the Visual Analogue Scale (VAS) for pain ii. Assessment of changes in Ayurvedic disease specific symptoms of sandhivata iii. Frequency of use of no. of NSAID / analgesic medication iv. Change in WOMAC Pain, stiffness, physical activity score i. Tolerability assessed by proportion of recruited participants remaining in the trial intervention, during the trial. Timepoint: baseline, 4th, 8th, 12th week and end of the 16th week | — |
Countries
India
Contacts
Public ContactSai Prasad A J V
RARI Vijayawada CCRAS New Delhi
Outcome results
None listed