Effectiveness of composite Ayurveda regimen in a black box design for the management of Rheumatoid arthritis

Phase 3

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

• Registration Number: CTRI/2023/07/055264
• Lead Sponsor: Central Council for Research In Ayurvedic Sciences CCRAS Ministry Of Ayush, Government Of India

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

Inclusion Criteria

1.Participants of age between 18 and 65 years, diagnosed with Rheumatoid arthritis (as per ACR 2010 criteria)

2.Participants willing to give written informed consent for participation in the study.

Exclusion Criteria

1.Participants presenting with complications of Rheumatoid Arthritis e.g. deformity of joints / bones, pleura-pericardial disease, or else

2.Participants with extra articular manifestations of RA and gastrointestinal symptoms

3.Participants with joint prosthesis and those who are unable to walk without support and / or confined to wheel chair

4.Participants with Hemoglobin <8 gm %

5.Participants diagnosed with other arthritis like osteoarthritis, gouty arthritis, tuberculous arthritis, Psoriatic arthritis, spondyloarthropathy, active fibromyalgia, juvenile chronic arthritis, ulcerative colitis, or other systemic inflammatory conditions and auto-immune diseases.

6.Participants having blood pressure >=160/100 mmHg, &/or HbA1C >8 %

7.Participants on medication with corticosteroids, antidepressants, anticholinergics, etc. Or Ayush interventions/folk medicine, or any other drugs that may have an influence on the outcome of the study

8.Participants with diagnosed concurrent neurological, pulmonary or endocrine disorder, or unstable cardio-vascular disease

9.Participants with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine > upper normal limit)

10.Participants with alcohol use disorder (AUD) (CAGE score >2) or any other substance abuse (Annexure II)

11.Pregnant / lactating woman.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Change in DAS-28 score with ESR <br/ ><br> <br/ ><br>Timepoint: â?¢Time Frame: Baseline & 84th day <br/ ><br> <br/ ><br>