Clinical study to compare the effect of Unani drug with aceclofenac in joints pain

A randomized, parallel group, open label, controlled clinical study to evaluate the safety and efficacy of a Unani Pharmacopoeial formulation â?? Habb-e-Baryuma in Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019237

Enrollment

Registered

2019-05-20

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: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Group A: Habb-e-Baryuma (Tablet): Habb-e-Baryuma in the dose of 5 pills (500 mg each) twice daily orally with water after meals Duration of Therapy: 6 weeks Control Intervention1: Group

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any sex in the age group 35-55 years Patients having Wajaâ??al-MafÄ?á¹£il (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)The 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

Exclusion criteria: Patients aged 55 years 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 Gastritis/ Peptic Ulcer Disease/ Renal Impairment 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 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 History of hypersensitivity to study drug or any of its ingredients Pregnant and lactating women 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
Visual Analogue Scale (VAS) Disease Activity Score in 28 Joints (DAS28) Swollen Joints Count (SJC) Tender Joints Count (TJC)Timepoint: At baseline, 2wk, 4wk, & 6wk	—

Secondary

Measure	Time frame
Lab InvestigationsTimepoint: At Baseline and After Treatment	—

Countries

India

Contacts

Public ContactDr Arzeena Jabeen

entral Research Institute Of Unani Medicine

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

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