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Ginseng in Treatment of Fatigue in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01712373
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, 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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Ginseng Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis
Study Start Date : December 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ginseng
Ginseng, tablet, 250 mg, twice, 3 months
Drug: Ginseng
it is kind of drug
Placebo Comparator: Placebo
Placebo, tablet
Drug: Placebo
it is placebo



Primary Outcome Measures :
  1. Fatigue [ Time Frame: 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 :
  1. Quality Of Life [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712373


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of, 7007
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: mahboobe esfahani, MD MD, Research Assistant

Additional Information:
Responsible Party: Hamidreza Shemshaki, research assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01712373     History of Changes
Other Study ID Numbers: ASD-1270
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Multiple sclerosis
Ginseng
Fatigue
Quality of life

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms