A Clinical trial to study the effect of Ksheerbala Taila Matra Basti and Therapeutic Combination of Vatari Guggulu, Maharasnadi Kwatha and Narayan Taila in the Management of Osteoarthritis Knee

Not Applicable

Completed

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Osteoarthritis Knee (Sandhivata)

• Registration Number: CTRI/2013/12/004241
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-03-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in WOMAC stiffness Domain Score <br/ ><br> <br/ ><br>Change in WOMAC Physical function Domain <br/ ><br> <br/ ><br>Global assessment of disease activity <br/ ><br> <br/ ><br>Change in the visual analogue scale (VAS) for pain in last 48 hrs <br/ ><br> <br/ ><br>Assessment of change in Ayurvedic disease specific symptoms of sandhi vata <br/ ><br>Timepoint: 14th day, 28th day, 42nd day, 56th day, and 70th day and 84th day & after 4 weeks of follow-up study