Effect of Melatonin on Multiple Sclerosis Related Fatigue

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Melatonin

Criteria

Inclusion Criteria:

1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria

2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0

3. aged between 18 and 55 years of either sex

4. treated with one type of interferon beta-1a (IFNB-1a);

5. signed an informed consent

Exclusion Criteria:

1. clinical relapsing of MS during past 30 days;

2. use of melatonin and warfarin within 30 days prior to participation;

3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ;

4. working more than one nighttime shift per month;

5. Pregnancy or lactation;

6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;

7. failure to adhere to the study protocol