â??A prospective community based study for the evaluation of YograjGuggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (JanugatSandhivata)â??

CCRAS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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
•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. < 30 minutes of morning stiffness
•iii.Crepitus on active motionand 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. < 30 minutes of morning stiffness
•iii.Crepitus on active motion
•iv.Bony tenderness
•v.Bony enlargement
•vi.No palpable warmth of synovium
•vii.ESR < 40mm/hour
•viii.Rheumatoid Factor (RF) < 1:40
•ix.Synovial fluid (SF) signs of osteoarthritis

•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/mÂ² 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

发起方

CCRAS New Delhi