To evaluate the Safety and efficacy of two Unani formulations Majun Jograj Gugal and Raughan-e-Malkangani in Wajaâ??al-Mafasil (Rheumatoid Arthritis)

Phase 2

• Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecifiedHealth Condition 2: null- Wajaâ??al-Mafasil (Rheumatoid Arthritis)

• Registration Number: CTRI/2015/03/005638
• Lead Sponsor: Central Council for Research in Unani Medicine New Delhi

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

•Patients of either sex in the age group 18-65 years.

•Patients having Wajaâ??al-Mafasil (rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV):

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, disseminated/ complicated herpes zoster (e.g., multi-dermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia), HIV infection or any other serious and/ or unstable illness that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.

•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 SGOT, SGPT, ALP, S. creatinine, B. urea, and uric acid outside the reference range (raised >3 times the ULN) that, in the opinion of the investigator, could pose an unacceptable risk to the participant.

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

•Pregnant and lactating women

•H/o Addiction (alcohol, drugs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified