NCT01712373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

October 19, 2012

Last Update Submit

October 22, 2012

Conditions

Fatigue

Keywords

Multiple sclerosisGinsengFatigueQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality Of Life

    at 3 months after treatment

Study Arms (2)

Ginseng

ACTIVE COMPARATOR

Ginseng, tablet, 250 mg, twice, 3 months

Drug: Ginseng

Placebo

PLACEBO COMPARATOR

Placebo, tablet

Drug: Placebo

Interventions

GinsengDRUG

it is kind of drug

Ginseng
PlaceboDRUG

it is placebo

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, 7007, Iran

Location

MeSH Terms

Conditions

FatigueMultiple Sclerosis

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • mahboobe esfahani, MD

    MD, Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 23, 2012

Study Start

December 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

IR(1)