Ginseng in Treatment of Fatigue in Multiple Sclerosis

Fatigue Clinical Trial

Official title:

Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712373
• Other study ID #: ASD-1270
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: October 22, 2012
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2012
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis

Intervention

Drug:
• Ginseng
it is kind of drug
• Placebo
it is placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 3 months after treatment	Yes
Secondary	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.	at 3 months after treatment	Yes

External Links

•   Isfahan university of medical science