Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-a and IL-1
Phase 3
Recruiting
- Conditions
- Rheumatoid Arthritis.Seropositive rheumatoid arthritis
- Registration Number
- IRCT20201101049223N1
- Lead Sponsor
- Gonabad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
Age between 18 to 65 years
Score 6 out of ten ACR / EULAR 2010
criteriaModerate-severe disease according to SDAI criteria (above 11)
Patients who continue to have joint pain and swelling despite receiving standard medications (methotrexate, hydroxychloroquine, sulfasalazine, and prednisolone).
The type of drug and its dose should be constant for at least 1 month before the study and remain the same during the study.
Filling in the written consent
Exclusion Criteria
pregnancy and lactation
diabetes melitus
HF with EF<40%
severe infection need IV antibiotics
smoking more than 10 cigarette per day
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aboratory response. Timepoint: At the beginning of the study and 3 months later. Method of measurement: based on simplified disease activity index (SDAI).;Clinical response to treatment (improved function of joints and morning dryness). Timepoint: At the beginning of the study and 3 months later. Method of measurement: Based on patient interview and clinical examination.;Serum level of ESR, CRP, IL-1, TNF-a. Timepoint: At the beginning of the study and 3 months later. Method of measurement: laboratory exam.
- Secondary Outcome Measures
Name Time Method Finally the patient is clinically. Timepoint: End of treatment. Method of measurement: Clinical examination and laboratory results.