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Ginseng in Treatment of Fatigue in Multiple Sclerosis

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ginseng
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Multiple sclerosis, Ginseng, Fatigue, Quality of life

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Al-zahra university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ginseng

Placebo

Arm Description

Ginseng, tablet, 250 mg, twice, 3 months

Placebo, tablet

Outcomes

Primary Outcome Measures

Fatigue
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

Quality Of Life
Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.

Full Information

First Posted
October 19, 2012
Last Updated
October 22, 2012
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01712373
Brief Title
Ginseng in Treatment of Fatigue in Multiple Sclerosis
Official Title
Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Multiple sclerosis, Ginseng, Fatigue, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginseng
Arm Type
Active Comparator
Arm Description
Ginseng, tablet, 250 mg, twice, 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, tablet
Intervention Type
Drug
Intervention Name(s)
Ginseng
Intervention Description
it is kind of drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
it is placebo
Primary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
at 3 months after treatment
Secondary Outcome Measure Information:
Title
Quality Of Life
Description
Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.
Time Frame
at 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mahboobe esfahani, MD
Organizational Affiliation
MD, Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
ZIP/Postal Code
7007
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical science

Learn more about this trial

Ginseng in Treatment of Fatigue in Multiple Sclerosis

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