Clinical trial phase II of oral hebal compoenent (BMP) in patient with multiple sclerosis
Phase 2
- Conditions
- Multiple Sclerosis.Demyelinating diseases of the central nervous systemG35, G36,
- Registration Number
- IRCT138803241696N2
- Lead Sponsor
- Iran Rheumatism Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Age between 18 and 50
Multiple sclerosis diagnosis by Mac Donald criteria
EDSS more than six
Signing informed consent
Exclusion criteria:
Sever hepatic/ Renal or cardiac diease
Sever psychological disorders
Adminstration of IVIG, Mitoxantrone, Plasmapheresis or immunosupressive drug since three months before
Pegnancy or intention to pregnancy
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in MRI (Magnetic Resonance Imaging). Timepoint: start of treatment, 6th and 12th month. Method of measurement: Magnetic Resonance Imaging.
- Secondary Outcome Measures
Name Time Method EDSS. Timepoint: Start of Treatment, 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th, and 12th month. Method of measurement: Asking from patients.;MSIS quality of life questionnaire. Timepoint: Start of Treatment, 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th, and 12th month. Method of measurement: Completing the questionnaire.