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IRCT20081208001497N9 IRCT 2021-08-20 Esfahan University of Medical Sciences Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches: A randomized, double blind, placebo controlled trial 2021-08-22 anticipated 60 Complete https://irct.ir/trial/57351 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomized by random blocking method with blocks of 4 which generated by Random Allocation software version 2. Blocking and allocation sequence for concealment will be done by the person not involved in the research (Allocation Concealment). The sample allocation ratio will be (1: 1 Allocation) and will be divided into two groups of drug recipients and placebo (Assignment). Drugs will then be given to patients based on the blocks obtained and in the order of allocation, Blinding description: This study will be performed as double-blind. The drug and placebo packing package and code allocation is done by the researcher involved in the research and then provided to the main researcher. In this way, the physician and patients will not know the contents of the packages and the type of codes and will not know which of the two control or test groups it belongs to. 3 Migraine. Intervention 1: Intervention group: Eligible patients receive regular migraine treatment with a 500 mg tablet of Iaraj Fiqra (NIAK Pharmaceutical Company) for two months. Common medications include triptans, ergotamine derivatives, analgesics like NSAIDs, acetaminophen, and anti-emetic drugs such as metoclopramide and corticosteroids. Intervention 2: Control group: They receive the usual treatments along with placebo pills. This pill is prepared by NIAK Pharmaceutical Company and contains exponents such as lactose and magnesium stearate without active ingredient. Yes - There is a plan to make this available What will be shared: Published article When: One year To whom: All people Conditions: No condition Where to obtain: Scientific responded of the study How to obtain: Email to corresponding author Comments:
public Sarah Mousavi
Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D
Isfahan Iran (Islamic Republic of) 81746 73461 +98 31 3792 7072 s.mousavi@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Sarah Mousavi
Hezar Jerib avenue, Isfahan University of Medical Sciences, Faculty of pharmacy, Clinical Pharmacy D
Isfahan Iran (Islamic Republic of) 81746 73461 +98 31 3792 7072 s.mousavi@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having migraine without aura (according to the criteria of the International Headache Association (HIS), which is diagnosed by the physician Age between 18 and 65 History of migraine of at least one year The first migraine attack at the age of less than fifty years Have at least three attacks per month in the last three months Having a score higher than 6 according to the MIDAS questionnaire 18 years 65 years Both Having headaches between two migraine attacks that are indistinguishable from migraine attacks Chronic tension headache or other types of headache for more than 15 days a month Pregnancy and lactation The presence of underlying heart problems such as arrhythmias History of biliary problems Comorbidities with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease History of hemorrhoids Concomitant use of sedatives such as phenobarbital Concomitant use of diuretics, oral corticosteroids Concomitant use of laxatives such as polyethylene glycol or magnesium hydroxide Daily consumption of migraine prophylaxis for the past month Take at least three migraine medications for prophylaxis over the past ten years Drug or alcohol abuse Patient dissatisfaction G43.0 Migraine without aura Treatment - Drugs Placebo Intervention group: Eligible patients receive regular migraine treatment with a 500 mg tablet of Iaraj Fiqra (NIAK Pharmaceutical Company) for two months. Common medications include triptans, ergotamine derivatives, analgesics like NSAIDs, acetaminophen, and anti-emetic drugs such as metoclopramide and corticosteroids. Control group: They receive the usual treatments along with placebo pills. This pill is prepared by NIAK Pharmaceutical Company and contains exponents such as lactose and magnesium stearate without active ingredient. Evaluation of the number of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6). Evaluation of the severity of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6). Evaluation of the duration of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6). Esfahan University of Medical Sciences Approved 2021-07-05 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)