Effect of sake yeast supplementation (Saccharomyces cerevisiae) and S-adenosyl methionine (SAM) on pharmacoresistant epilepsy
Phase 3
- Conditions
- pharmacoresistant epilepsy.Epileptic seizures related to external causes, not intractable, with status epilepticusG40.501
- Registration Number
- IRCT20180119038433N4
- Lead Sponsor
- Semnan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Pharmacoresistant epileptic patients
Patients who have not responded to any of the anticonvulsant drugs on the market for at least one year
Exclusion Criteria
Cancelation
Uncontrolled blood pressure
Malignancy
History of alcoholism or drug abuse,
Pregnancy
Lactation
Unreliable clinical records
Patients who does not take medication
Patients who does not attend the clinic orderly
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seizure response (daily seizure frequency). Timepoint: Number (frequency) of seizures in patients with drug-resistant epilepsy at the beginning of the study (before the start of the study), at the end of each week after the start of the study and eventually up to two months after the end of the study. Method of measurement: Questionnaire, electroencephalograph (EEG) , physical examination.
- Secondary Outcome Measures
Name Time Method Memory function score. Timepoint: Evaluation of memory function by recording scores in patients with drug-resistant epilepsy at the beginning of the study (before the start of the study), at the end of each week after the start of the study and eventually up to two months after the end of the study. Method of measurement: Questionnaire and physical examination.;Depression score. Timepoint: Evaluation of severity of depression by recording scores in patients with drug-resistant epilepsy at the beginning of the study (before the start of the study), at the end of each week after the start of the study and eventually up to two months after the end of the study. Method of measurement: Questionnaire and physical examination.