Effect of nano formulation of saffron crocin in patients with multiple sclerosis
- Conditions
- multiple sclerosis.Multiple sclerosis
- Registration Number
- IRCT20120227009157N7
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
•Willingness to participate in the study•
Age range between 18 to 60 years old
Diagnosis of relapse remission multiple sclerosis according to the McDonalds 2010 criteria and taking B-interferon as treatment
Diagnosis of mild to moderate according to DSM V(Diagnostic and Statistical Manual of Mental Disorders, 5th edition) by a neurologist and Beck Depression Inventory (BDI-II) (score from 11 to 20)
EDSS lower than 5.5
Pregnancy (or having a planned pregnancy) or Lactation
Allergy or sensibility to the drugs at the beginning of their treatments
History of allergy or sensibility to Saffron or its components
Receiving IVIG during the last six months of treatment
Increase of liver enzymes three times more than normal value
Stop taking drugs for more than forth months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Minimal Assessment of Cognitive Function in MS (MACFIMS) total score. Timepoint: baseline. Method of measurement: after 12-week intervention.
- Secondary Outcome Measures
Name Time Method Total score of beck's depression inventory. Timepoint: baseline. Method of measurement: after 12-week intervention.