A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis knee.

Phase 2

Completed

• Conditions: Health Condition 1: null- osteoarthritis knee

• Registration Number: CTRI/2014/02/004388
• 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
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1.Patient with Primary Osteoarthritis (knee) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology.

2. Pain in the affected joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale).

3. Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in WOMAC total scoreTimepoint: at baseline,at 84th day and at the end of follow up after 16 weeks.

Secondary Outcome Measures

Name	Time	Method
1.Change in WOMAC stiffness Domain Score <br/ ><br>2.Change in WOMAC Physical function Domain <br/ ><br>3. Global assessment of disease activity <br/ ><br>Change in the visual analogue scale (VAS) for pain in last 48 hrs. <br/ ><br>5.Assessment of change in Ayurvedic disease specific symptoms of Sandhi vata.Timepoint: At baseline,14th day,28th day,42nd day,56th day,70th day,84th day and at the end of follow up after 16 weeks.