Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Yograj Guggulu: Yograj Guggulu (AFI – Part I, 5 : 7).
Dose :1gm (2 Tablets) twice daily
Dosage form :Tablet of 500 mg each
Route of Administration: Orally
Time of Administration: Tw
Sponsors
Ministry of Tribal Affairs
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant of any gender in the age group 40-65 yrs of Scheduled Tribe 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
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/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, Indian WOMAC (Modified –CRD Pune Version)Timepoint: i.At Baseline, End of 4th week, End of 8th week, End of 12th Week, and End of 16th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Change in the Visual Analogue Scale for pain ii. Assessment of changes in Ayurvedic disease specific symptoms of sandhivata(sandhishula , Sandhishotha,Akunchana prasaranayoh vedana,Stambha,sandhisphutana ) iii. Frequency of use of no. of NSAID/analgesic medication iv. Change in WOMAC Pain,stiffness,physical activity score v. Tolerability assessed by proportion of recruited participants remaining in the trial intervention, during the trial. Timepoint: at baseline, 4th, 8th,12th week and end of the 16th week | — |
Countries
India
Contacts
Public ContactDr Kalpana B Kachare
Central Council for Research in Ayurvedic Sciences , New Delhi
Outcome results
None listed