Treatment of Rheumatoid Arthiritis with Unani formulations

Phase 2

Recruiting

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

• Registration Number: CTRI/2013/12/004199
• Lead Sponsor: Monetary Support 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 ul Mafasil (Rheumatoid Arthritis).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. 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 end of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Patients of either sex in the age group of 20-60 •Patients fulfilling the ACR criteria for rheumatoid arthritis i.e the 2010 American College of Rheumatology/European League Against Rheumatism classification Criteria for rheumatoid arthritis.

Exclusion Criteria

• •Patients having Gout, or complicated rheumatoid arthritis associated with deformity.
• •Abnormality in any investigation done at baseline (SGOT, SGPT and ALP,Sr Creatinine, B.Urea would be considered abnormal if raised 2 ½ times the normal value ) •Overweight subjects – BMI 35 •Disorders requiring long term treatment •Drug addicts ( Alcohol, drugs ) •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms	12 weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	12 weeks

Trial Locations

Locations (3)

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

Regional Research Institute of Unani Medicine (RRIUM), Chennai; 🇮🇳 Chennai, TAMIL NADU, India

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

Central Research Institute of Unani Medicine (CRIUM),

🇮🇳Lucknow, UTTAR PRADESH, India

DR A B ALVI

Principal investigator

05222361720

abalvi@rediffmail.com