CTRI/2021/07/034925
Not yet recruiting
Phase 3
â??A prospective community based study for the evaluation of YograjGuggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (JanugatSandhivata)â??
CCRAS New Delhi0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Sponsor
- CCRAS New Delhi
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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. \< 30 minutes of morning stiffness
- •iii.Crepitus on active motion
- •iv.Bony tenderness
- •v.Bony enlargement
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
Outcomes
Primary Outcomes
Not specified
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