Ginseng in Treatment of Fatigue in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01712373
First received: October 19, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Fatigue
Drug: Ginseng
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Fatigue [ Time Frame: at 3 months after treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 3 months after treatment ] [ Designated as safety issue: Yes ]
    Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.


Enrollment: 60
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Hamidreza Shemshaki, research assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01712373     History of Changes
Other Study ID Numbers: ASD-1270
Study First Received: October 19, 2012
Last Updated: October 22, 2012
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 23, 2014