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IRCT20201129049534N2 IRCT 2021-06-23 Esfahan University of Medical Sciences Effect of phytosomal curcumin supplementation on patients with migraine The effect of phytosomal curcumin supplementation on severity, frequency, duration of headache and inflammatory factors and oxidative stress in patients with migraine 2022-04-04 anticipated 70 Complete https://irct.ir/trial/56657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples generate random numbers using a reputable website: https://www.sealedenvelope.com/simple-randomiser/v1/lists. They are randomly assigned to one of two phytosomal curcumin or placebo supplements, Blinding description: For researchers to be blind, phytosomal curcumin and placebo capsules are purchased equally from Sami labs Ltd., India in shape, colour and size. These capsules are coded by someone other than the researchers (A and B) and the researcher distributes them without knowing the type of capsules. Patients and researchers will not be aware of the capsule-type until the end of the study. 3 Migraine headache. Intervention 1: The intervention group will receive a capsule containing Phytosomal curcumin in the amount of 250 mg of curcumin once a day after breakfast for 8 weeks. Intervention 2: The control group will receive capsule (1 capsule) containing a placebo. Each capsule contains 250 mg of maltodextrin for 8 weeks. Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who agree to participate in the study and complete the informed consent form. Diagnosis of migraine headache by a neurologist using the third edition of the International Headache Disorders Questionnaire. Age: 18 to 80 years old 18 years 80 years Both Taking anticoagulants such as warfarin, heparin, aspirin, etc. Pregnancy and lactation Follow a special diet in the last 3 months Use of herbal supplements in the last 3 months G44.3 Migraine headache Treatment - Drugs Placebo The intervention group will receive a capsule containing Phytosomal curcumin in the amount of 250 mg of curcumin once a day after breakfast for 8 weeks. The control group will receive capsule (1 capsule) containing a placebo. Each capsule contains 250 mg of maltodextrin for 8 weeks. Severity of migraine headache. Timepoint: At baseline and end of the study. Method of measurement: VAS scale. Frequency of migraine headache. Timepoint: At baseline and end of the study. Method of measurement: Number of migraine headache attacks per month. Duration of migraine headache. Timepoint: At baseline and end of the study. Method of measurement: The average duration of migraine headache attacks per hour per headache. Quality of life. Timepoint: At baseline and end of the study. Method of measurement: Questionnaire. Sleep quality. Timepoint: At baseline and end of the study. Method of measurement: Sleep quality questionnaire. Malondialdehyde (MDA). Timepoint: At baseline and end of the study. Method of measurement: Calorimetry. Superoxide dismutase (SOD). Timepoint: At baseline and end of the study. Method of measurement: Calorimetry. Total oxidant status (TOS). Timepoint: At baseline and end of the study. Method of measurement: Calorimetry. Total Antioxidant Capacity (TAC). Timepoint: At baseline and end of the study. Method of measurement: Calorimetry. C reactive protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: Elisa. Nitric Oxide (NO). Timepoint: At baseline and end of the study. Method of measurement: Elisa. Esfahan University of Medical Sciences Approved 2021-06-09 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan School of Nutrition and Food Sciences, Isfahan University of Medical Sciences,Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)