Ginseng in Treatment of Fatigue in Multiple Sclerosis
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
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
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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 May 23, 2013