Effect of Saffron on Rheumatoid Arthritis treatment

Phase 2

• Conditions: Rheumatoid Arthritis.; Rheumatoid arthritis, unspecified

• Registration Number: IRCT2014071218453N1
• Lead Sponsor: Vice Chancellor for Research of Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

To have four criteria of ACR-1987 for Rheumatoid Arthritis; New patients who haven’t received any standard treatment up to the time of the study; Patients over 18 years old.
Exclusion criteria: Pregnancy; Breast-feeding; Diagnosed sensitivity to saffron; Diagnosed hepatic and renal diseases; Other comorbid rheumatologic diseases; Malignancies and/or active infections; Diagnosed psychological diseases.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease activity level according to DAS28-ESR score. Timepoint: Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: Using determined formula for DAS28-ESR which is according to physical examinations, ESR level, and patient self-assessment.

Secondary Outcome Measures

Name	Time	Method
HAQ-DI. Timepoint: Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to HAQ-DI questionnaire which is translated to Persian and its validation has been assessed.;EULAR response. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to EULAR criteria table on the basis of DAS28-ESR score.;Saffron pill adverse effects. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to check list containing known adverse effects of Saffron.