Effects of a Persian Herbal Extract in treatment of Multiple Sclerosis Patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2017
INTERVENTION: control group: patients will receive placebo twice a day for 4 weeks. 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 extract contains 15 mg saffron, 60 mg vitis vinifera, 200 mg cinnamon and 500 mg hypericum performatum. Intervention 2: control group: patients will receive placebo twice a day for 4 weeks. 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 mg saffron, 60 mg vitis vinifera, 200 mg cinnamon and 500 mg hypericum performatum. Placebo Treatment ‐ Drugs CONDITION: Demyelinating diseases of the central nervous system multiple sclerosis. ; Demyelinating diseases of the central nervous system PRIMARY OUTCOME: Depression. Timepoint: baseline and endpoint. Method of measurement: Beck depression inventory. SECONDARY OUTCOME: 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). 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.
Epistemonikos ID: 6dbc97ee5b592265a14f8724f8de01de73440512
First added on: Mar 31, 2022