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IRCT20121216011763N36 IRCT 2019-01-25 Esfahan University of Medical Sciences Cinnamon, Inflammatory markers and anthropometric indices in patients with Migraine The effect of cinnamon consumption on symptoms, severity of headache, inflammatory markers and anthropomethric indices among patients with migraine headache 2018-08-23 anticipated 44 Complete https://irct.ir/trial/35715 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Subjects will be assigned to blocks, based on gender. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random number table, Blinding description: This is a double-blind clinical trial (participant, researcher) study. The cinnamon capsules and placebo will be produced by Faculty of Pharmacy, Isfahan University of Medical Sciences. Cinnamon capsules and placebo will be in the package with the same shape and color and the patients and researcher will not aware of the content of the pack until the end of the trial. N/A Condition 1: Migraine. Condition 2: Migraine. Intervention 1: The Intervention group will receive three capsules each containing 600 mg of cinnamon powder after each 3 main meals per day for 8 weeks. Cinnamon capsule will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences. Intervention 2: The control group will receive three placebo capsules (600 mg of corn starch) after each 3 main meals for 8 weeks.The placebo will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Major part of informations will be available for population. When: starting 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: Dr. Gholamreza Askari via email: askari@mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Azadeh Zareie
Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 a_z.zarei@yahoo.com Esfahan University of Medical Sciences scientific Gholamreza Askari
Hezarjarib Ave.
Isfahan 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) Aged 20-50 years old Diagnose of migraine by a neurologist willing to participate in the study 20 years 50 years Both Pregnancy and breastfeeding Menopause consumption of antioxidants and cinnamon supplements history of cinnamon sensitivity and allergy having tension headaches having chronic diseases such as chronic kidney diseases, gastrointestinal diseases and Alzheimer's G43.0 G43.1 Migraine without aura Migraine with aura Treatment - Other Placebo The Intervention group will receive three capsules each containing 600 mg of cinnamon powder after each 3 main meals per day for 8 weeks. Cinnamon capsule will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences. The control group will receive three placebo capsules (600 mg of corn starch) after each 3 main meals for 8 weeks.The placebo will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences. Severity of migraine attacks. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: VAS scale. Frequency of migraine attacks. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: Questionnaire. Duration of migraine attacks. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: Questionnaire. Migraine Disability Assessment Questioner (MIDAS). Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: Questionnaire. Interleukin 6 (IL6). Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Calcitonin Gene-Related Peptide (CGRP). Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Weight. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: Mechanical scales. Waist Circumference. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: non-stretching tape measure. Waist / hip ratio - WHR. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: non-stretching tape measure. Body Mass Index. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter. Esfahan University of Medical Sciences Approved 2018-09-02 Ethics committee of Isfahan University of Medical Sciences Hezarjarib street Isfahan Isfehan Iran (Islamic Republic of)