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Ginseng in Treatment of Fatigue in Multiple Sclerosis

NCT ID: NCT01712373

Last Updated: 2012-10-23

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study was to evaluate the efficacy and safety of Ginseng 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 Ginseng 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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Ginseng

Ginseng, tablet, 250 mg, twice, 3 months

Group Type ACTIVE_COMPARATOR

Ginseng

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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Ginseng

it is kind of drug

Intervention Type DRUG

Placebo

it is placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria with a baseline of Expanded Disability Status Score (EDSS)of less than 5.0

Exclusion Criteria

* prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin, aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior to enrollment;
* Pregnancy or lactation;
* history of renal failure; and,
* lack of appropriate adherence to the study protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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

Principal Investigators

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mahboobe esfahani, MD

Role: PRINCIPAL_INVESTIGATOR

MD, Research Assistant

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-1270

Identifier Type: -

Identifier Source: org_study_id