Effectiveness of composite Ayurveda regimen for management of Rheumatoid arthritis

Phase 3

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

• Registration Number: CTRI/2023/06/054203
• Lead Sponsor: Ministry of AYUSH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• 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.

11.Pregnant / lactating woman.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Change in DAS-28 score with ESR.Timepoint: •Time Frame: Baseline and 84th day

Secondary Outcome Measures

Name	Time	Method
•Frequency of use of conventional analgesic/NSAIDs medicinesTimepoint: Time Frame: Baseline, 28th day, 56th Day & 84th day;•Assessment of any adverse eventsTimepoint: Time Frame: From baseline upto 84th day;•Change in Disability Index score (The Indian Health Assessment Questionnaire)Timepoint: Time Frame: Baseline, 28th day, 56th Day & 84th day;•Change in disease specific biochemical & inflammatory markers (RA factor, CRP, ESR)Timepoint: Time Frame: Baseline & 84th day;•Change in Participants Assessment of Pain [assessed through Visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain)Timepoint: Time Frame: Baseline, 28th day, 56th Day & 84th day;•Change in Participants Global Assessment of Disease Activity assessed through Visual analog scaleTimepoint: Time Frame: Baseline, 28th day, 56th Day & 84th day