Treatment of Arthritis (pain in joints) by Unani medicine Habb-e-Irq un Nisa

Clinical Validation of Unani Pharmacopoeial Formulation Habb-e-Irq un Nisa in Wajaâ??al-MafÄ?sil (Rheumatoid Arthritis)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026543

Enrollment

300

Registered

2020-07-14

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: Habb-e-Irq un Nisa: 2 Tablets Orally Daily To be taken with water after meals for 12 weeks Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex in the age group 18-65 years. 2. 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

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. Known case 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.

Design outcomes

Primary

Measure	Time frame
Improvement in signs and symptoms of Wajaâ??al-MafÄ?sil (Rheumatoid Arthritis)Timepoint: 12 Weeks	—

Secondary

Measure	Time frame
Haematological and biochemical assessment for safety assessmentTimepoint: Investigations will be done at baseline and end of treatment. After 12 weeks of treatment.	—

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

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