Development and validation of an instrument for assessing the disease activity in inflammatory arthritis

Not Applicable

• Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

• Registration Number: CTRI/2022/04/042098
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Diagnosable as aamvata as per ayurvedic criteria and RA as per ACR criteria.

2.Having the symptoms for not less than 3 months.

4.Should not have taken any long acting steroids or disease modifying anti rheumatic drugs in past three months which may have modified the status of ama related features.

5. Should not have taken any NSAIDS or short acting steroids during past 12 hours from the time of actual interrogation.

Exclusion Criteria

1. Patients having any other joint pathology besides RA(amavata).

2. Patients having ama related systemic pathology eg. obesity, hypothyroidism, diabetes,hepatostetosis, etc. to rule out this every prospective participants will be screened by Random Blood sugar, BMI, TSH, and serum alkaline phosphatase.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of an Ama assessment instrument for its use as a disease activity indicator in patients of Amavata ( RA)Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
1. Assessing the reliability of the instrument <br/ ><br>2. Assessing the validity of the instrument with various standard disease activity scores, markers and patient related outcome measures in RA like ESR, CRP, DS 28 score , patient assessment of pain on VAS scale, brief PHQ, HAQ, FACIT-F Score <br/ ><br>3. To see the feasibility of Ama score as a patient related outcome measure ( PROM) to evaluate the therapeutic benefits of a given ayurvedic intervention used in Ama related joint pathology. <br/ ><br>Timepoint: 6 months