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Study aim:
To assess the phytochemical and clinical effect of a herbal medicine containing mint, rosemary, lavender, and clove compared to placebo on the prevention and control of migraine symptoms
Design:
This is a Phase III triple-blind randomized clinical trial with a control group with parallel groups, in which 155 eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct:
This study will be conducted at the School of Pharmacy in Hamadan city, involving 155 eligible patients with migraine. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be triple-blinded.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
Age 18 to 55 years,
Diagnosis of migraine,
Experience of at least 4 migraine attacks in the past three months,
Exclusion criteria:
Use of similar herbal medicines in the past 2 months,
Pregnancy or breastfeeding,
Presence of other neurological disorders such as epilepsy or multiple sclerosis,
Use of antidepressant or anticonvulsant medications in the past 2 months
Intervention groups:
Intervention group 1:
Routine treatment plus herbal medicine containing mint applied
Intervention group 2:
Routine treatment plus herbal medicine containing rosemary applied
Intervention group 3:
Routine treatment plus herbal medicine containing lavender applied
Intervention group 4:
Routine treatment plus combined herbal medicine containing clove
Control group:
Routine treatment plus placebo without any herbal ingredient
Main outcome variables:
Primary outcome:
Number of migraine attacks
Headache severity
Mean duration of migraine attacks
Secondary outcome:
Improvement in sleep quality
Amount of analgesic medication use
Mean mood and anxiety score before
Mean patient satisfaction score before