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IRCT20121216011763N56 IRCT 2023-03-26 Esfahan University of Medical Sciences The effect of black grape seed extract supplement in patients with migraine The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine 2023-06-22 anticipated 50 Complete https://irct.ir/trial/69159 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done based on the stratified randomization method. To distribute patients into intervention and control groups, first, persons are classified into four states according to the type of migraine (with aura/without aura) and body mass index (18.5 to 24.9 and 25 to 30). Then, persons with the same conditions will be randomly assigned to two intervention and control groups. For this purpose, the first person who referred will be in the intervention group and the other person with the same conditions will be in the control group, Blinding description: This study is a double-blind clinical trial study (participant, outcome assessor). The black grape seed extract supplement and its placebo (identical in terms of color, shape, and taste) will be packaged in similar boxes, and the participants and the outcome assessor will not be informed of the contents of the packages until the end of the study. 3 Migraine. Intervention 1: Intervention group: Two capsules of black grape seed extract daily (containing 100 mg of black grape seed extract, Daru Pajhuh-e-Jaber company) for eight weeks. Intervention 2: Control group: Two placebo capsules daily (containing calcium phosphate, Avicel, and gelatin, Daru Pajhuh-e-Jaber company) for eight weeks. 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 There is no further information.

public Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3060 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3060 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are willing to participate in the study Migraine diagnosis by a neurologist based on the International Classification of Headache Disorders-3 (ICHD-3) Age 18 to 60 years Having at least one migraine attack per month Body mass index between 18.5 to 30 18 years 60 years Both Suffering from chronic kidney diseases, cancer, and other neurological disorders Suffering from tension-type headaches Change in the type of medicine used and its dosage during the last month Pregnancy and lactation Taking supplements containing antioxidants and black grape seed extract in the last 3 months Following a special diet G43 Migraine Treatment - Drugs Placebo Intervention group: Two capsules of black grape seed extract daily (containing 100 mg of black grape seed extract, Daru Pajhuh-e-Jaber company) for eight weeks Control group: Two placebo capsules daily (containing calcium phosphate, Avicel, and gelatin, Daru Pajhuh-e-Jaber company) for eight weeks. Severity of migraine attacks. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Visual Analogue Scale (VAS). Migraine disability. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Headache Impact Test-6 questionnaire (HIT-6). Calcitonin gene-related peptide (CGRP) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (ELISA). Vascular cell adhesion molecule-1 (VCAM-1) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (ELISA). Malondialdehyde (MDA) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (colorimetric method). Serum level of total antioxidant capacity (TAC). Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (colorimetric method). Migraine frequency. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Question / Number of attacks per month. Duration of migraine headache. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Question/ average duration of migraine attacks per headache (hours). Quality of life in migraine patients. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Migraine-Specific Quality of Life (MSQ). Depression. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21). Anxiety. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21). Stress. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21). Blood pressure. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Mercury barometer. Anthropometric indices. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: A digital scale and standard stadiometer. Esfahan University of Medical Sciences Approved 2023-03-07 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)