The effect of omega-3 versus placebo on the clinical and paraclinical signs and symptoms of drug-resistant epileptic patients: a triple blind randomized clinical trial

Objectives: Omega-3 as a polyunsaturated fatty acid has anti-inflammatory effects. In previous studies, it has been demonstrated that the frequency of seizures, associated with some of inflammatory factors. So we decided to study the effects of omega-3 on the symptoms and inflammatory markers in patients with refractory drug resistant epilepsy. Design: This study is a triple-blind clinical trial which will be carried out on 40 patients with refractory epilepsy. Setting and conduct: Patients were randomly divided into two groups of 20 people. At the beginning and at the end of treatment protocol, 5 ml blood sample per patient is taken and the level of inflammatory factors TNF-α and IL-6 in their blood serum will be measured by ELISA. During the study, also frequency and intervals of epileptic attacks will be recorded. Participants including major eligibility criteria: Inclusion criteria: generalized epilepsy resistant to treatment: 18 to 65 years Exclusion criteria: Catamenial epilepsy; Patients with impaired renal function ... Intervention: The test group will receive (600 mg twice a day) omega-3 as a adjuvant therapy in the treatment. The control group also will receive placebo twice daily (Placebo is made by Zahravi pharmaceutical company) for a period of 4 months as a test group (It should be noted that patients do not consume omega-3 drug one week per month). main outcome measures (variables): It is clear that the primary outcome variable is the frequency of seizures.

Vice-chancellor for research and technology Hamadan university of medical sciences