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Effect of Melatonin on Multiple Sclerosis Related Fatigue

NCT ID: NCT01718678

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Conditions

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Fatigue

Keywords

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Multiple sclerosis Melatonin Fatigue Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Melatonin

Melatonin, Tablet, 3 mg, once, one month

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

it is kind of drug

Placebo

Placebo, tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

It is Placebo

Interventions

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Melatonin

it is kind of drug

Intervention Type DRUG

Placebo

It is Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Shemshaki

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-12111

Identifier Type: -

Identifier Source: org_study_id