igella Sativa oil for treatment of Behcet's disease
Phase 1
- Conditions
- Behcet’s Disease.Behcet’s Disease, unspecified
- Registration Number
- IRCT201511086975N5
- Lead Sponsor
- Vice chancellor for research, Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Age older than 16; Having active Behcet’s disease: Iranian's Behcet's Disease Dynamic Activity Measure (IBDDAM) more than 2.5
Exclusion criteria: Consumption of Nigella Sativa oil supplements in the past 8 weeks; Pregnancy and lactation; Liver disease; Renal insufficiency
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Behcet's disease activity. Timepoint: Before, 2, 4, and 6 months after intervention. Method of measurement: Iranian's Behcet's disease activity measure.;Plasma levels of TNF-a, IL-10, oxidant and antioxidant systems (total antioxidant, malondialdehyde). Timepoint: Before and 2 months after intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay.
- Secondary Outcome Measures
Name Time Method igella Sativa oil side effects. Timepoint: 2, 4, and 6 months after intervention. Method of measurement: Questionnaire.