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IRCT20121216011763N45 IRCT 2020-04-22 Esfahan University of Medical Sciences The effect of synbiotic supplement in migraine The effect of synbiotic supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine 2020-07-22 anticipated 80 Complete https://irct.ir/trial/47256 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). synbiotic 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. N/A Migraine. Intervention 1: Intervention group: Two capsule of synbiotic 500 mg daily half an hour before dinner and lunch for 12 weeks. Intervention 2: Control group: Two capsule of starch 500 mg daily half an hour before dinner and lunch for 12 weeks. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: askari@mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request Comments:
public Abed ghavami
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 abedghavami@gmail.com Esfahan University of Medical Sciences scientific Gholamreza Askari
Hezar Jarib
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who agree to participate in the study Diagnosis of migraine by a neurologist according to ICHD-3 Aged between 20 to 50 years old 20 years 50 years Female Non-compliance with dietary recommendations and supplements(Use less than 80% of the prescribed supplement) Reaction and sensitivity to the prescribed supplement Lack of referral in different stages of study G43.0 Migraine without aura Treatment - Drugs Placebo Intervention group: Two capsule of synbiotic 500 mg daily half an hour before dinner and lunch for 12 weeks Control group: Two capsule of starch 500 mg daily half an hour before dinner and lunch for 12 weeks Migraine symptoms (severity, frequency, duration of migraine). Timepoint: At baseline and after 12 weeks. Method of measurement: Questionnaire (Visual analogue scale (VAS) and Clinical examination). Serum levels of Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. 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. Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire. Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life(MSQ)questionnaire. Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. 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. Esfahan University of Medical Sciences Approved 2020-03-04 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)