Ginseng in Treatment of Fatigue in Multiple Sclerosis

Phase 2

Completed

• Conditions: Fatigue
• Interventions: Drug: Placebo; Drug: Ginseng

• Registration Number: NCT01712373
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-10
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Last Update Submitted: 2012-10-22
• Study First Posted: 2012-10-23
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, tablet
Ginseng	Ginseng	Ginseng, tablet, 250 mg, twice, 3 months

Primary Outcome Measures

Name	Time	Method
Fatigue	at 3 months after treatment	Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects.

Secondary Outcome Measures

Name	Time	Method
Quality Of Life	at 3 months after treatment	Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of