multiple sclerosis. Demyelinating diseases of the central nervous system
Conditions
Interventions
Intervention 1: Intervention group: The patients in the intervention group will be treated with 10 milliliters of the herbal extract twice a day for 4 weeks. Each 10-milliliter dose of the herbal extr
Treatment - Drugs
Placebo
Intervention group: The patients in the intervention group will be treated with 10 milliliters of the herbal extract twice a day for 4 weeks. Each 10-milliliter dose of the herbal extract contains 15
control group: patients will receive placebo twice a day for 4 weeks.
Sponsors
Vice Chancellor for research of Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression. Timepoint: baseline and endpoint. Method of measurement: Beck depression inventory. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam adalat
Tabriz University of Medical Sciences
Outcome results
None listed