A comparative Clinical Study to evaluate the safety and efficacy of a unani formulation in the Management of Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis)

A Randomized, Active-Controlled, Assessor-Blinded, Parallel Group Clinical Study to evaluate the safety and efficacy of Qurs-e-Mafasil in the Management of Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis) - RCT RA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024187

Enrollment

Registered

2020-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Qurs-e-Mafasil: Qurs-e-Mafasil in the dose of 2 tablets (500mg each) twice daily orally with water after meals for 4 weeks Control Intervention1: Celecoxib 100mg: Celecoxib in the dose

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any sex in the age group 35-55 years Patients diagnosed with Wajaâ??al-MafÄ?á¹£il (Rheumatoid arthritis) on the basis of following ACR-EULAR criteria 1)Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 2)Absence of an alternative diagnosis for the observed synovitis (arthritis) 3)Achievement of a total score of 6 or greater(of a possible 10) 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

Exclusion criteria: Patients aged 55 years Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse) 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 Currently receiving or have intra-articular treatment (e.g. corticosteroids, or NSAIDS within 2 weeks of study entry and DMARDs or IFN therapy within 4 wks prior to study entry or are anticipated to require IFN therapy during study History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment History of hypersensitivity to study drug or any of its ingredients Pregnant or Lactating Women Hypertensive and Obese Subjects (BMI>=30) H/o Addiction (alcohol, drugs) Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies Patient not willing to attend treatment schedule regularly

Design outcomes

Primary

Measure	Time frame
Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: 1) Visual Analogue Scale (VAS) 2) Disease Activity Score in 28 joints (DAS28)27Timepoint: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: 1) Visual Analogue Scale (VAS) 2) Disease Activity Score in 28 joints (DAS28)27	—

Measure

Time frame

Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: 1) Visual Analogue Scale (VAS) 2) Disease Activity Score in 28 joints (DAS28)27Timepoint: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: 1) Visual Analogue Scale (VAS) 2) Disease Activity Score in 28 joints (DAS28)27

—

Secondary

Measure	Time frame
Lab investigation and X-rayTimepoint: 0,2, 4 weeks	—

Countries

India

Contacts

Public ContactDr Mohammad Nawab

National Research Institute of Unani Medicine for Skin Disorders

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026