Effects of a Persian Herbal Extract in treatment of Multiple Sclerosis Patients
Not Applicable
- Conditions
- multiple sclerosis.Demyelinating diseases of the central nervous system
- Registration Number
- IRCT2016012916369N3
- Lead Sponsor
- Vice Chancellor for research of Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
definite diagnosis of MS; age range of 18 to 50 years old; Expanded Disability Status Score (EDSS) of less than or equal to 6; no disease attack during the previous month; no history of other autoimmune diseases; disease stable status during last three months; presence of depression, fatigue and sleep disorder symptoms; not using other antioxidant or herbal supplement during study.
Exclusion criteria: evidence of dementia or psychosis; cardiovascular disease; diabetes; severe depression; clinically significant major infections; pregnancy and breastfeeding status; disease attack during the study; not willingness to continue the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression. Timepoint: baseline and endpoint. Method of measurement: Beck depression inventory.
- Secondary Outcome Measures
Name Time Method Fatigue and sleep disorders. Timepoint: baseline and endpoint. Method of measurement: fatigue severity scale (FSS), modified fatigue impact scale (MFIS), insomnia severity scale (ISI) and Pittsburgh sleep quality index (PSQI).