Effect of Unani treatments on blood parameters in Rheumatoid arthritis patients

Phase 2

• Conditions: Health Condition 1: M048- Other autoinflammatory syndromes

• Registration Number: CTRI/2023/05/052589
• Lead Sponsor: 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: 4 March 2024

Recruitment & Eligibility

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

Inclusion Criteria

Patients of either sex in the age group 18-65 years. Patients having Waja‘al-Maf ?sil (Rheumatoid arthritis) as defined by the following

ACR-EULAR criteria (Annexure IV)i.e.,

1) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint

2) Absence of an alternative diagnosis for the observed synovitis (arthritis)

3) A total score of at least 6 from the individual scores in 4 domains:

a. Number and site of involved joints (range 0-5)

b. Serological abnormalities (range 0-3)

c. Elevated acute-phase reactants (range 0-1)

d. Duration of symptoms (range 0-1)

Exclusion Criteria

Rheumatoid arthritis with extra-articular manifestations, joint deformities, and

advanced radiological lesions (e.g. joint subluxation and collapse). Obese subjects (BMI =30). History or clinical evidence of any systemic inflammatory condition other than RA

such as, juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active

vasculitis, or gout that may interfere with evaluation.

History or clinical evidence of any serious systemic illness, DM, TB, HIV infection

etc

Are currently receiving or have received intra-articular treatment (e.g., corticosteroids

or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of

study entry and DMARDs or IFN therapy within 4 weeks prior to study entry or are

anticipated to require IFN therapy during the study.

Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside

the reference range, and SGOT, SGPT raised >2.5 times the ULN.

History of hypersensitivity to study drug or any of its ingredients.

Pregnant and lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified