A scientific study to know how much the Kenacort Injection is safe and effective in the patients of bone joint health issues.

Not Applicable

• Conditions: Health Condition 1: M069- Rheumatoid arthritis, unspecified

• Registration Number: CTRI/2020/07/026408
• Lead Sponsor: Dr Chandrashekara S

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

Inclusion Criteria

1. Patient has a confirmed diagnosis of Rheumatoid Arthritis and on stable therapy for RA in the last 3 months as per ACR 2010 criteria.

2. Evidence of disease flare-up in the knee joint

3. Patient on at least 1 DMARD for the past 6 month

4. Stable dose of DMARD in the last 6 weeks

5. Patients who require intra-articular glucocorticoid injection in the knee joint.

6. Participants should have the ability to understand the requirements of the study.

7. Participants willing to abide by the study restrictions and return for the required assessments.

8. Participants willing to provide an written informed consent

Exclusion Criteria

1. Patients not willing to give informed consent

2. Patients with only mild disease

3. Patients currently on intravenous or depo steroids.

4. In the Principal Investigatorâ??s opinion patient who may require changes in current DMARDs including its dose strength during the study duration.

5. Patients with septic arthritis

6. Any other clinically significant disorder which needs treatment or serious systemic illness

7. Alcoholics and/or drug abusers.

8. Known history of hypersensitivity to the trial drug or any of its ingredients.

9. Pregnant / lactating woman.

10. Patients who have completed participation in any other clinical trial during the past six (06) months.

11. 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
To assess and compare the mean change in severity of pain measured by VAS score from baseline to week 2 visit. <br/ ><br>To assess and compare the mean change in reduction of swelling on the Likert scale from baseline to week 2 visit. <br/ ><br> <br/ ><br>Timepoint: Week 2

Secondary Outcome Measures

Name	Time	Method
To assess and compare the mean change in frequency and duration of morning stiffness from Baseline to Week 6 & Week 12 visit <br/ ><br>To compare the pattern of frequency morning stiffness between two different arms <br/ ><br>To assess and compare the mean change in severity of pain & mobility measured by VAS score from Baseline to Week 6 & Week 12 visit <br/ ><br>To assess and compare the mean change in reduction of swelling on the Likert scale from baseline to week 6 & week 12. <br/ ><br>Timepoint: week 6 and week 12