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IRCT20121216011763N21 IRCT 2017-12-03 Esfahan University of Medical Sciences Effect of combined supplementation Coenzyme Q10 with L-carnitine on migraine Effect of combined supplementation Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders markers and migraine symptoms among patient with migraine by following a tyramine-controlled diet. 2017-05-22 anticipated 56 Complete https://irct.ir/trial/11958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In present study, simple randomization method will be used. The randomization unit is individually and we will use the random number table method for random sequences. A random numbered table is a collection of numbers that are without a specific pattern, completely random and as table. The next step is allocation concealment and will use sequentially numbered, sealed, opaque envelopes. Then, based on the sample size, number of envelopes with aluminum surface are provided and each random sequence created on a card and the cards are inserted into the envelopes, respectively. At the time of registration for the participants, according to eligible participants, one of the envelopes is opened and the allocated group for participants is revealed, Blinding description: The present study is a double blind method and participants, researcher, and statistical analyser will not know according to assigned intervention. 0 (exploratory trials) migraine. Intervention group: 30 mg/day Coenzyme Q10 with 250 mg/day L-carnitine at the same time for 8- weeks control group: placebo tablets for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available
public Parisa Hashemi
Hezarjarib streetÙˆ Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8135798111 +98 31 3792 3171 hashemi_p@yahoo.com Isfahan University of Medical Sciences scientific Mojgan nourian
Hezarjarib streetÙˆ Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8135798111 +98 31 3792 3172 nourian@hlth.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) patients with migraine (with or without aura) both sex nonpregnant nonlactative nonsmokers non-alcoholic willing to participate in the study 20 years 40 years Both contain history of chronic diseases chronic tension-type headache or secondary headaches medication or supplements use following a diet program during the past 6 month following exercise program during the past 6 month G43.9 Migraine, unspecified Treatment - Drugs Intervention group: 30 mg/day Coenzyme Q10 with 250 mg/day L-carnitine at the same time for 8- weeks control group: placebo tablets for 8 weeks Migraine symptoms ( severity , frequency and average duration of migraine attacks). Timepoint: week 0 and week 8. Method of measurement: Questionaire. Serum Lactate. Timepoint: week 0 and week 8. Method of measurement: Laboratory analysis (blood test). Migraine Disability Assessment. Timepoint: week 0 and week 8. Method of measurement: Questinaire. Depression. Timepoint: week 0 and week 8. Method of measurement: Questinaire. Esfahan University of Medical Sciences Approved 2017-05-01 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)