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IRCT20250114064378N1 IRCT 2025-02-09 Zahedan University of Medical Sciences Investigating the Effect Of Coenzyme 10 (Q10) in Controlling Migraine Headaches in Women 18-45 Years Old Investigating the Effect Of Coenzyme 10 (Q10) in Controlling Migraine Headaches in Women 18-45 Years Old 2025-02-08 anticipated 40 Complete https://irct.ir/trial/81407 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a double blind randomized parallel clinical trial. The target population includes people with migraines referred to Baharan Hospital in Zahedan, which are diagnosed by a neurologist based on the criteria of the International Headache Association. Random allocation will be done using Block Randomization and blocks of four.And half of the cases are assigned to the intervention group and half of the cases to the control group. All four states are as follows. which in NL A is group one and B is group two. The four states are as follows. which in NL A is group one and B is group two. 1- A A B B 2- A B A B 3- A B B A 4- B B A A 5- B A B A 6- B A A B In the next step, we assign one of the numbers 1 to 6 to each of these four combinations.In the next step, based on the overall sample size and the sample size of the groups, we select about 20 blocks of four randomly and determine their order. Allocation of people to the intervention and control groups will be based on the selected arrangements. By continuing this process, we are sure that the difference between the two groups will not exceed two people at most, Blinding description: If the individual is placed in the intervention group, this group will be given a fixed and routine medication (propranolol 20 to 40 mg with sodium valproate 200 to 400 mg) along with coenzyme Q10 in the form of 100 mg capsules, one per day for three months. For blinding, the control group will be given a placebo in the same color, dosage, and instructions for taking coenzyme Q10, along with the fixed medication, in addition to the routine treatment. Follow-up will be for at least three months and patients will be contacted periodically to ensure medication use. After the follow-up period, patients will be re-evaluated for migraine headache severity. In addition, the two intervention and control groups will be matched in terms of the type of anti-migraine medication used and the dosage of the medication. 3 Migraine headache. Intervention 1: Intervention group: This group is given a fixed and routine medication (propranolol 20 to 40 mg plus sodium valproate 200 to 400 mg) along with coenzyme Q10 in the form of 100 mg capsules, one per day for three months. Intervention 2: Control group: Along with the fixed drug, a placebo will be given in the same color and dosage and instructions for taking Coenzyme 10 drug, along with the routine treatment. Placebo will be prepared in cooperation with Zabul University of Medical Sciences Faculty of Pharmacy. Yes - There is a plan to make this available What will be shared: I can share information about the main outcome. When: "Access period begins 6 months after results are published." To whom: For researchers working in academic and scientific institutions Conditions: Scientific uses Where to obtain: To access information, you can email b.izadpanahi@zaums.ac.ir or call 09155683822. How to obtain: A transparent request on the site for access to data by the individual, followed by review of the request by the Vice President for Research within 2 weeks, and then permission to access the data. Comments:
public Dr. Behnaz Izadpanahi
West Imam Khomeini St, Silo Block, Opposite Grain Office, Baharan Psychiatric Hospital, Zahedan Zahedan
Zahedan Iran (Islamic Republic of) 9819713955 +98 54 3351 3778 b.izadpanahi@zaums.ac.ir Zahedan University of Medical Sciences scientific Dr. Behnaz Izad panahi
West Imam Khomeini St, Silo Block, Opposite Grain Office, Baharan Psychiatric Hospital, Zahedan Zahedan
Zahedan Iran (Islamic Republic of) 9819713955 0098 5433513777-80 b.izadpanahi@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Women Aged 18 to 45 Informed Consent to Participate in The Study Completeness of Patient File Information and Records Diagnosis of The Disease By a Doctor Definitive Diagnosis of Migraine 18 years 45 years Female Suffering from chronic diseases Secondary headache or other types of primary headache except migraine Taking food supplements or medicine Pregnant and lactating women Smokers & alcoholics History of significant side effects or recent use of melatonin supplements Chronic mental illness and a history of severe depression during the last year G43.9 Migraine, unspecified Treatment - Drugs Placebo Intervention group: This group is given a fixed and routine medication (propranolol 20 to 40 mg plus sodium valproate 200 to 400 mg) along with coenzyme Q10 in the form of 100 mg capsules, one per day for three months. Control group: Along with the fixed drug, a placebo will be given in the same color and dosage and instructions for taking Coenzyme 10 drug, along with the routine treatment. Placebo will be prepared in cooperation with Zabul University of Medical Sciences Faculty of Pharmacy. Severity of headache attacks. Timepoint: day. Method of measurement: Patient statements. Frequency of headache attacks. Timepoint: Number. Method of measurement: Patient statements. Duration of headache. Timepoint: Clock. Method of measurement: Patient statements. Zahedan University of Medical Sciences Approved 2024-11-30 Ethics committee of Zahedan University of Medical Sciences Dr.Hesabi Square, Sistan and Baluchestan Province, ZahedanŲŒ Integrating the campus of the University of Medical SciencesŲŒ Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)