Multiple Sclerosis. Disseminated Multiple Sclerosis
Conditions
Interventions
Intervention 1: Saffron tablet, chemical formulation the stigma of the Saffron plant, (500 milligram three times a day, oral) for 12 months, made in Drug Unit, School of Pharmacy in Tehran University
Treatment - Drugs
Placebo
Saffron tablet, chemical formulation the stigma of the Saffron plant, (500 milligram three times a day, oral) for 12 months, made in Drug Unit, School of Pharmacy in Tehran University of Medical Scien
Placebo tablet, chemical formulation filling materials used in the preparation of pharmaceutical products (500 milligram three times a day, oral) for 12 months, made in Drug Unit, School of Pharmacy i
Sponsors
Vice President, Science and Technology Branch
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients with Relapsing- Remitting Multiple Sclerosis based on McDonald's Criteria 2.age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) 0- 5.5 4. Under treatment with Betaferon or Extavia 5. Signing consent form. -Exclusion criteria: 1. Being pregnant during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3. Allergy or hypersensitivity reaction to Saffron in the start of trial 4. Treatment with Intravenous immunoglobulin (IVIG) within six months prior to trial 5.Impaired Liver Function Tests (more than three times normal range) 6. Lack of medication more than four weeks.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse Rate. Timepoint: Before intervention and every three months after intervention. Method of measurement: Physical examination done by neurologist and EDSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| EDSS Expanded Disability Status Scale. Timepoint: Before intervention and every three months after intervention. Method of measurement: Physical examination done by neurologist based on revised Mc-Donald (2010).;Number and size of plaques. Timepoint: Before intervention and every six months after intervention. Method of measurement: Magnetic resonance Imaging ( MRI ). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Amir Reza Azimi
Sina Hospital
Outcome results
None listed