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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 system
G35, 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
NameTimeMethod
Changes in MRI (Magnetic Resonance Imaging). Timepoint: start of treatment, 6th and 12th month. Method of measurement: Magnetic Resonance Imaging.
Secondary Outcome Measures
NameTimeMethod
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.
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