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IRCT20120215009014N611 IRCT 2026-05-19 Hamedan University of Medical Sciences 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 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 2026-06-22 anticipated 155 Recruiting https://irct.ir/trial/90137 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Migraine. Intervention 1: Intervention group 1: Routine treatment plus herbal medicine containing mint applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention 2: Intervention group 2: Routine treatment plus herbal medicine containing rosemary applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention 3: Intervention group 3: Routine treatment plus herbal medicine containing lavender applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention 4: Intervention group 4: Routine treatment plus combined herbal medicine containing clove applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention 5: Control group: Routine treatment plus placebo without any herbal ingredient applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Dorsa Mahdizade
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 mahdizadedorsa1379@gmail.com Hamedan University of Medical Sciences scientific Dr. Dara Dastan
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 d.dastan@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 55 years, Diagnosis of migraine, Experience of at least 4 migraine attacks in the past three months, 18 years 55 years Both 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 G43 Migraine Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Routine treatment plus herbal medicine containing mint applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention group 2: Routine treatment plus herbal medicine containing rosemary applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention group 3: Routine treatment plus herbal medicine containing lavender applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Intervention group 4: Routine treatment plus combined herbal medicine containing clove applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Control group: Routine treatment plus placebo without any herbal ingredient applied as local massage on the temples, neck, forehead, and behind the ears three times per week for one month. Number of migraine attacks. Timepoint: Before intervention and one month later. Method of measurement: By medical history. Headache severity. Timepoint: Before intervention and one month later. Method of measurement: Using the Visual Analogue Scale (VAS). Mean duration of migraine attacks. Timepoint: Before intervention and one month later. Method of measurement: By medical history. Improvement in sleep quality. Timepoint: Before intervention and one month later. Method of measurement: Using the Pittsburgh Sleep Quality Index (PSQI). Amount of analgesic medication use. Timepoint: before intervention and one month later. Method of measurement: By medical history. Mean mood and anxiety score. Timepoint: before intervention and one month later. Method of measurement: Using the Depression Anxiety Stress Scales - 21 (DASS-21). Mean patient satisfaction score. Timepoint: Before intervention and one month later. Method of measurement: Using a researcher-designed questionnaire. Hamedan University of Medical Sciences Approved 2026-05-09 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)