Treatment of Rheumatoid Arthritis(pain and swelling in joints) with Unani medicines Majoon-e-Azaraqi and Roghan-e-Surkh

Phase 3

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

• Registration Number: CTRI/2021/05/033636
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM 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: 0

Inclusion Criteria

1. Subjects of either sex in the age group 18-65 years.

2. Subjectshaving total score of >=6/10 in ACR-EULAR criteria for diagnosis of Wajaâ??al-Mafasil (Rheumatoid Arthritis)

Exclusion Criteria

1. Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).

2. Obese subjects (BMI >=30)

3. 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.

4. 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.

5. Screening laboratory test values, including SGOT, SGPT, ALP, S. creatinine, B. urea, and S. 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.

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

7. Pregnant and lactating women

8. H/o Addiction (alcohol, drugs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of Waja-ul-Mafasil (Rheumatoid Arthritis)Timepoint: 2 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessmentTimepoint: at baseline and 12 weeks