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

Phase 3

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified,

• Registration Number: CTRI/2020/07/026543
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Waja‘al-MafÄsil (Rheumatoid Arthritis)****.** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation *Hab-e-Irq un Nisa*two tablets orally daily with water after meals for 12 weeks.  The patients will be assessed at every 2 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of *Hab-e-Irq un Nisa***

| | | | |

| --- | --- | --- | --- |

|S.No.

Ingredients

Botanical Name

Quantity

|1.

Sibr

*Aloe Barbadensis*

3.5 g

|2.

Post Halela Zard

*Terminalia Chebula*

3.5 g

|3.

Suranjan Shireen

*Colchicum Luteum*

3.5 g

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-18
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients of either sex in the age group 18-65 years.
• Patients having Waja‘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) 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Waja‘al-MafÄsil (Rheumatoid Arthritis)	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Investigations will be done at baseline and end of treatment. After 12 weeks of treatment.

Trial Locations

Locations (3)

Central Research Institute of Unani Medicine (CRIUM); 🇮🇳 Lucknow, UTTAR PRADESH, India

Regional Research Centre (RRC); 🇮🇳 Allahabad, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM); 🇮🇳 Patna, BIHAR, India

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Mohd Tariq

Principal investigator

8299875352

drtariqnium@gmail.com