A clinical trial to assess the efficacy of Ayurveda treatment in Jaanu Sandhigatavata (Primary Knee Osteoarthritis)

Phase 2

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of knee

• Registration Number: CTRI/2022/05/042792
• 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: 25 July 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients between 40 to 70 years having diagnosed Knee osteoarthritis (OA) as per the ACR criteria with the following parameters will be included in the study:

1.Pain score of at least 2 (Numeric Pain rating scale) in most days of the last month;

2.American College of Rheumatology (ACR) functional status criteria class I, II and III

3.Serum vitamin D level of >30 ng/ml

4.Able and willing to give informed consent

ACR criteria

Pain in knee + Any 3 of the following:

Age > 50 years

Less than 30 minutes of stiffness

Crepitus

Bony tenderness

Bony enlargement

No palpable warmth

Exclusion Criteria

Patients with the following criteria will be excluded from the study:

1.Grade 4 and above radiographic changes in the affected knee (Kellgren-Lawrence classification)

2.Significant trauma to the knee including arthroscopy within preceding one year

3.History of knee joint replacement

4.BMI>=32 kg/m²

5.History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study

6.On corticosteroids

7.Rheumatoid arthritis, Psoriatic arthritis, Lupus

8.Uncontrolled HTN ( >160/100 mm Hg)

9.Uncontrolled DM (HbA1c >8.0)

10.Cardiac, hepatic or renal function impairment

11.History or active malignancy

12.Tendency for occurrence of recurrent renal calculi

13.Hypersensitivity to trial drugs

14.History or active substance abuse/ alcoholism

15.Any contraindication for MRI scan

16.Any other condition that in the opinion of the investigator may compromise the participantâ??s safety or compliance, interfere with evaluation or preclude completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knee pain and functional disability from baseline assessed through WOMAC index scoreTimepoint: At baseline,30th day, 60th day, 90th day, 120th day, 150th day and 180th day.

Secondary Outcome Measures

Name	Time	Method
1.Change in score for pain, stiffness and physical function of WOMAC from baseline <br/ ><br>2.Change in the range of motion of knee joint (assessed through goniometer) <br/ ><br>3.Change in the score of Numeric Pain rating scale from baseline <br/ ><br>4.Change in Pain Disability Index score from baseline <br/ ><br>5.Change in health related quality of life from baseline assessed through SF-12 questionnaire <br/ ><br>6.Change in inflammatory biomarkers (highly sensitive C-reactive protein, IL-6) <br/ ><br>7.Change in the need of Rescue Analgesic medication <br/ ><br>8.Change in knee structural changes assessed through MRI <br/ ><br>9.Change in Bone mineral density assessed through DEXA scan <br/ ><br>10.Incidence of AE/ADRTimepoint: At baseline,30th day, 60th day, 90th day, 120th day, 150th day and 180th day.