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IRCT201604179014N96 IRCT 2016-04-26 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of omega-3 versus placebo on the clinical and paraclinical situation in patients with refractory epilepsy Effect of omega-3 versus placebo on the clinical and paraclinical situation in patients with refractory epilepsy: a triple blind randomized clinical trial 2015-09-11 anticipated 50 Complete https://irct.ir/trial/9534 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of six. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 Refractory epilepsy. Intervention 1: Routine treatment plus oral omega-3 one tablet 1000 mg twice a day for 4 months. Intervention 2: Routine treatment plus a placebo tablet twice a day for 4 months.
public Dr Shaghayegh Omrani
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3827 4184 drshaghayeghomrani@yahoo.com Farshchian Hospital scientific Dr Mehrdokht Mazdeh
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3827 4184 mehrdokhtmazdeh@yahoo.com Farshchian Hospital Iran (Islamic Republic of) Inclusion criteria: (a) age of 18 to 55 years; (b) having refractory epilepsy. Exclusion criteria: (a) pregnancy or breastfeeding; (b) having underling diseases such as lever disease, kidney disease, active infection, pulmonary disease, hypertension, dementia, and mental retardation; (c) catamenial epilepsy. 18 years 55 years Both G40 Epilepsy Treatment - Drugs Placebo Routine treatment plus oral omega-3 one tablet 1000 mg twice a day for 4 months Routine treatment plus a placebo tablet twice a day for 4 months Assessing the frequency of seizures. Timepoint: before treatment and every month for 4 months. Method of measurement: by taking history. Assessing serum level of interleukin-6. Timepoint: before treatment and 4 months later. Method of measurement: by laboratory test. Assessing serum level of TNF-α. Timepoint: before treatment and 4 months later. Method of measurement: by laboratory test. Assessing electroencephalogram changes. Timepoint: before treatment and 4 months later. Method of measurement: by taking electroencephalogram. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-01-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)