Effect of Unani medicine Habb-e-Suranjan in Waja ul Mafasil (Rheumatoid Arthritis)

Phase 2

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, Waja ul Mafasil (Rheumatoid Arthritis),

• Registration Number: CTRI/2018/08/015451
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is  a multicentric open trial in patients with **Waja ul Mafasil (Rheumatoid Arthritis)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every two 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 *Habb-e-Suranjan*(NFUM-I, Page 33) 

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical / English Name**

**Quantity**

|1.

Suranjan Shirin

*Colchicum autumnale* Linn.

1 Part

|2.

Post-i Halela Zard

*Terminalia citrina*

1 Part

|3.

Shahm-i Hanzal

*Citrullus colocynthis* (Linn.) Schrad.

1 Part

|4.

Muqil

*C. mukul* (Hook. ex Stocks) Engl.

1 Part

|5.

Turbud

*Operculina turpethum* (Linn.) S.

1 Part

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-07-12
• Study Start: 2018-08-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients of either sex in the age group 18-65 years.
• Patients having Waja‘al-MafÄsil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV): (i) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint (ii) Absence of an alternative diagnosis for the observed synovitis (arthritis) (iii) 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.
• History or clinical evidence of any serious systemic illness, DM, TB, HIV infection etc 5.
• 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.
• Screening laboratory test values, including S.
• Creatinine, BUN, S.
• Bilirubin outside the reference range, and SGOT, SGPT raised >2.5 times the ULN.
• History of hypersensitivity to study drug or any of its ingredients.
• Pregnant and lactating women.

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)	Six Weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	6 weeks

Trial Locations

Locations (3)

Regional Research Centre; 🇮🇳 Cachar, ASSAM, India

Regional Research Institute of Unani Medicine; 🇮🇳 JAMMU, & KASHMIR, India

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE; 🇮🇳 Bhadrak, ORISSA, India

Regional Research Centre

🇮🇳Cachar, ASSAM, India

Dr Akhtar Hussain Jamali

Principal investigator

8811907160

crukxj522@gamail.com