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IRCT20121216011763N66 IRCT 2026-05-05 Esfahan University of Medical Sciences The effect of Moringa Oleifera supplement in migraine Investigating the effect of supplementation with Moringa Oleifera on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in patients with migraine 2026-06-22 anticipated 80 Pending https://irct.ir/trial/89767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random chain will be extracted from the site, Blinding description: This study is a double blind clinical trial (participant, researcher). Inulin supplement and placebo (identical from color, shape and odor) will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packs until the end of the study. 3 Migraine. Intervention 1: Intervention group: Participants will receive 1000 mg of Moringa oleifera supplement daily (two 500 mg tablets) for 12 weeks. Intervention 2: Control group: Participants will receive two 500‑mg placebo tablets containing starch daily for 12 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 +98 913 266 3418 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 3222 2127 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The patient must agree to participate in the study. The diagnosis of migraine must be confirmed by a neurologist according to the ICHD-3 criteria. The patient must be aged between 20 and 50 years. 20 years 50 years Both Non-compliance with dietary recommendations and supplements, defined as consuming less than 80% of the prescribed supplement. Development of a reaction or sensitivity to the prescribed supplement. Failure to attend follow-up visits at different stages of the study. Diagnosis of tension-type headaches. Diagnosis of gastrointestinal disorders such as Crohn’s disease or ulcerative colitis, or other neurological disorders. Pregnancy or lactation. Use of nutritional supplements, including probiotics or prebiotics, within the last three months. Following a special diet. Use of antibiotics or antacid drugs within the past three months. Migraine G43 Treatment - Drugs Treatment - Drugs Intervention group: Participants will receive 1000 mg of Moringa oleifera supplement daily (two 500 mg tablets) for 12 weeks. Control group: Participants will receive two 500‑mg placebo tablets containing starch daily for 12 weeks. Clinical symptoms of migraine (severity, frequency, duration of migraine attacks). Timepoint: At baseline and after 12 weeks. Method of measurement: Visual Analogue Scale (VAS) questionnaire and clinical examination. Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21 questionnaire. Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life (MSQ) questionnaire. Physical activity. Timepoint: At baseline and after 12 weeks. Method of measurement: International Physical Activity Questionnaire (IPAQ). Anthropometric indices. Timepoint: At baseline and after 12 weeks. Method of measurement: Seca scale and portable stadiometer. Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co. Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co. Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Serum lactate levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co. Serum malondialdehyde levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co. Serum interleukin-6 levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Esfahan University of Medical Sciences Approved 2026-04-20 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)