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Effect of Traditional Medicine Product on MS-related Fatigue

Not Applicable
Conditions
Condition 1: Neurasthenia, Malaise and fatigue. Condition 2: Multiple Sclerosis.
Neurasthenia, Malaise and fatigue
Multiple sclerosis
F48, R53
Registration Number
IRCT2014050317545N1
Lead Sponsor
Vice Chancellor for Research of Faculty of Traditional Iranian Medicine of Tehran University of Medi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
70
Inclusion Criteria

MS diagnosis, either relapsing remitting (RR) secondary progressive (SP) or primary progressive, based on specified criteria of modern medicine by MC.Donald criterion approved with neurologist; MS-related fatigue lasting at least one month and there should be indication of anti fatigue treatment; consciously accepting subscription form/ letter of satisfaction; patient shouldn't be under simultaneous anti-fatigue medical treatment; not using any other natural or herbal treatment by the patient during the study; lack of any record of sensitivity to drug ingredients; EDSS equal or less than 6; MFIS more than 45; no crisis of disease over the previous 60 days and Exclusion criteria: relapse of disease over the study period; uncontrolled diabetes; blood hypertension; pregnant or lactating mothers; severe infection; severe mental disorders

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Modified Fatigue Impact Scale (MFIS) Standard Questionnaire. Timepoint: Before intervention and after four weeks. Method of measurement: Filling out Modified Fatigue Impact Scale (MFIS) Standard Questionnaire by the patient.;Visual Analog Scale (VAS) for Fatigue. Timepoint: Before intervention and after four weeks. Method of measurement: Filling out Visual Analog Scale (VAS) by the patient.
Secondary Outcome Measures
NameTimeMethod
Sleep Quality of patients contributed in the study. Timepoint: Before intervention and after four weeks. Method of measurement: Filling out Pittsburgh Sleep Quality Index (PSQI) by the patient.;Constipation in patient. Timepoint: Before intervention and after four weeks. Method of measurement: Filling out Rome III Criteria for constipation module by the patient.
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