Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: null- Osteoarthritis Knee (Sandhivata)
Conditions
Interventions
Intervention1: Vatari Guggulu,Maharasnadi Kwatha ,Narayan Taila, Ksheerbala Taila Matra Basti: Vatari Guggulu 500mg 2 Tablets thrice daily with Lukewarm Water after food orally for 12 weeks
Maharasnad
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex, aged between 30 and 65 years. Patient with primary osteoarthritis Knee joint(s) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology. Pain in the affected Knee joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale) Willing and able to participate in the study for 16 weeks
Exclusion criteria
Exclusion criteria: Patients with Grade IV Kellgren & Lawrence Radiological scale History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s). Gross disability in performing daily normal routine i.e. bedridden patients or confined to a wheelchair. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis. Patients having any deformity of knee hip or back altering the gait and posture of the patient. Patients with uncontrolled hypertension (160/100 mm of Hg). Patients with uncontrolled diabetes mellitus{B.S. (F) 126 mg% and / or B.S. (2 hr. PP) 200 mg% and or HbA1c6.5% Patients with evidence of malignancy. Patients on prolonged ( 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. Patients who have a past history of atrial fibrillation, acute coronary syndrome, myocardial infarction, stroke or severe arrhythmia in the last 6 months. Patients with any severe renal or hepatic or any other disorder which may interfere in the study. Pregnant / lactating woman. Patients who are currently participating in any other clinical trial. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC total scoreTimepoint: 14th day, 28th day, 42nd day, 56th day, and 70th day and 84th day and after 4 weeks of follow-up study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in WOMAC stiffness Domain Score Change in WOMAC Physical function Domain Global assessment of disease activity Change in the visual analogue scale (VAS) for pain in last 48 hrs Assessment of change in Ayurvedic disease specific symptoms of sandhi vata Timepoint: 14th day, 28th day, 42nd day, 56th day, and 70th day and 84th day & after 4 weeks of follow-up study | — |
Countries
India
Contacts
Public ContactDr Renu Singh
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed