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: a triple-blind randomized clinical trial

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

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.

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.

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 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

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

Random allocation of patients into intervention and control groups is done by lottery. For this purpose, we prepare five cards: on four cards we write the names of the interventions, and on one card we write the name of the placebo. Then, upon each patient's arrival, we randomly draw one card without replacement and assign the patient to either the intervention or the control group.

The drugs will be administered in coded envelopes. Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. The distributer of the medicines will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a triple-blind study.