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IRCT20170315033086N11 IRCT 2023-05-31 Shahid Beheshti University of Medical Sciences Study the effect of CAPRIDIN in the metabolic treatment of drug-resistant epilepsy Study the effect of metabolic treatment based on a diet containing CAPRIDIN on adenosine regulatory pathways in brain tissue of patients with drug-resistant epilepsy 2023-06-05 anticipated 10 Complete https://irct.ir/trial/69426 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: - "Random Allocation V.2" software is used for randomization. This software can be downloaded from the following link: https://random-allocation-software.software.informer.com In this study, one block is used for the randomization. - Patients will be allocated in two intervention and control groups in equal numbers. 1-2 Drug-resistant temporal lobe epilepsy. Intervention 1: Intervention group: patients who take 30 cc of CAPRIDIN daily with food, in addition to the standard treatment of epilepsy, for an average of two months. Capridin is a product of HealthWeX (Canada) that contains medium chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Treatments based on ketogenesis in the control of epilepsy are among the approved treatments for this disease. Intervention 2: Control group: patients are receiving only standard epilepsy treatment. Antiepileptic drugs are often used as the first line of treatment and as standard treatment. The most important antiepileptic drugs include phenobarbital, carbamazepine, phenytoin, valproic acid, lamotrigine, and levetiracetam. Depending on the specialist doctor's diagnosis and the individual's clinical conditions, any of these drugs may be prescribed for patients. Yes - There is a plan to make this available What will be shared: Collected deidentified IPD, IPD collected for the primary outcome measure only. When: Deidentified data will be available starting from March 2026 To whom: Who are working in academic institutions or working in nutritional companies. . Conditions: No specific condition. Where to obtain: Saeed Karima (Floor 8, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran. Iran) Email: karima@sbmu.ac.ir How to obtain: The process: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided within one month. Comments:
public Saeed Karima
Department of Clinical Biochemistry, Shahid Behehshti University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 karima@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Abbas Tafakhori
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1420 Imamhospital@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with drug-resistant temporal lobe epilepsy Taking up to 3 or more standard anticonvulsants Having at least 3 seizures per month. 15 years 65 years Both Failure to adhere to dietary guidelines. Metabolic syndrome Pregnancy G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures N/A N/A Intervention group: patients who take 30 cc of CAPRIDIN daily with food, in addition to the standard treatment of epilepsy, for an average of two months. Capridin is a product of HealthWeX (Canada) that contains medium chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Treatments based on ketogenesis in the control of epilepsy are among the approved treatments for this disease. Control group: patients are receiving only standard epilepsy treatment. Antiepileptic drugs are often used as the first line of treatment and as standard treatment. The most important antiepileptic drugs include phenobarbital, carbamazepine, phenytoin, valproic acid, lamotrigine, and levetiracetam. Depending on the specialist doctor's diagnosis and the individual's clinical conditions, any of these drugs may be prescribed for patients. Expression level of ecto-5-nucleotidase (CD73) in the patients brain tissue. Timepoint: Two months after taking CAPRIDIN and then brain tissue sampling after surgery. Method of measurement: Using Real-Time PCR and Western blot techniques. Expression level of adenosine kinase in the patients brain tissue. Timepoint: Two months after taking CAPRIDIN and then brain tissue sampling after surgery. Method of measurement: Using Real-Time PCR and Western blot techniques. Behbalin Inc. Approved 2023-02-21 Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences and Health S Shahid Chamran highway - Evin - next to Taleghani hospital - medical school - ground floor Tehran Tehran Iran (Islamic Republic of)