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IRCT20161203031212N3 IRCT 2020-11-09 Esfahan University of Medical Sciences The effect of alpha-lipoic acid on migraine. The effects of alpha-lipoic acid supplementation on oxidative stress status, inflammatory markers, VCAM-I serum levels, lactate and clinical symptoms in women with migraine. 2020-10-22 anticipated 90 Complete https://irct.ir/trial/48979 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Randomization within each block will be done based on a table of random numbers using a valid random number generation website.Reputable website for generating random numbers: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Supplementary and placebo packages will be prepared and coded by Raha Pharmaceutical Company and are completely the same in terms of all appearance, color, smell and label, and each patient is randomly assigned a number using the order obtained from the reputable website. And the researcher and patients will not be informed of the contents of the packages until the end of the study. 3 migraine. Intervention 1: People will receive 300 mg of alpha-lipoic acid supplement twice a day for 3 months. The supplement and placebo will be provided by Raha Pharmaceutical Company. Intervention 2: The control group will receive an alpha-lipoic acid placebo twice daily for 3 months. Supplements and placebo will be provided by Raha Pharmaceutical Company. 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 At the end of the study, information will be provided to participants.
public Dr Amir Mansour Alavi
Hezarjarib Ave
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3154 am.alavi@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Amir Mansour Alavi
Hezarjarib Ave
Isfahan Iran (Islamic Republic of) 81746-73461 37923154 am.alavi@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participation in the study. Diagnosis of migraine by a neurologist based on ICHD-3 criteria. Age 20 to 50 years. Non-menopausal women. 20 years 50 years Female History of any allergies, intolerances or adverse drug reactions to the supplement. Pregnancy and lactation. History of intestinal bypass. Follow a special diet for the past 6 months. Smoking or alcohol. Take any supplements. Cardiovascular disease, diabetes, liver, kidney, thyroid, malignant disease and other neurological disorders are diagnosed based on the patient interview. Start taking the new drug within the last 1 month G43.0 Migraine without aura Treatment - Other Placebo People will receive 300 mg of alpha-lipoic acid supplement twice a day for 3 months. The supplement and placebo will be provided by Raha Pharmaceutical Company. The control group will receive an alpha-lipoic acid placebo twice daily for 3 months. Supplements and placebo will be provided by Raha Pharmaceutical Company. Migraine severity. Timepoint: At baseline and after 3 month. Method of measurement: Visual analogue scale. Migraine frequency . Timepoint: At baseline and after 3 month. Method of measurement: Clinical examination. Migraine duration. Timepoint: At baseline and after 3 month. Method of measurement: Clinical examination. Headache impact test. Timepoint: At baseline and after 3 month. Method of measurement: HIT questionnaire. C-reactive protein (CRP). Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Serum glutathion. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Total antioxidant capacity. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Total oxidant capacity. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Malondialdehyde. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Vascular cell adhesion molecule-1. Timepoint: At baseline and after 3 month. Method of measurement: It will be measured by ELISA kit. Serum lactate. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Serum Nitric Oxide. Timepoint: At baseline and after 3 month. Method of measurement: Colorimetric method. Depression. Timepoint: At baseline and after 3 month. Method of measurement: DASS questionnaire. Anxiety. Timepoint: At baseline and after 3 month. Method of measurement: DASS questionnaire. Stress. Timepoint: At baseline and after 3 month. Method of measurement: DASS questionnaire. Esfahan University of Medical Sciences Approved 2020-10-11 Ethics committee of Isfahan University of Medical Sciences Hezarjarib street Isfahan Isfehan Iran (Islamic Republic of)