Saffron in treatment of Multiple Sclerosis

Phase 2

• Conditions: Multiple Sclerosis.; Disseminated Multiple Sclerosis

• Registration Number: IRCT138802091859N1
• Lead Sponsor: Vice President, Science and Technology Branch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse Rate. Timepoint: Before intervention and every three months after intervention. Method of measurement: Physical examination done by neurologist and EDSS.

Secondary Outcome Measures

Name	Time	Method
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 ).