A prospective study of Osteoarthritis Knee (Janugat Sandhivata) ?

Not Applicable

Completed

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

Registration Number: CTRI/2021/07/034964

Lead Sponsor: Ministry of Tribal Affairs

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 490

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
i.Change in the Visual Analogue Scale for pain <br/ ><br>ii.Assessment of changes in Ayurvedic disease specific symptoms of sandhivata(sandhishula , Sandhishotha,Akunchana prasaranayoh vedana,Stambha,sandhisphutana ) <br/ ><br>iii.Frequency of use of no. of NSAID/analgesic medication <br/ ><br>iv.Change in WOMAC Pain,stiffness,physical activity score <br/ ><br>v.Tolerability assessed by proportion of recruited participants remaining in the trial intervention, during the trial. <br/ ><br>Timepoint: at baseline, 4th, 8th,12th week and end of the 16th week