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IRCT20180119038433N4 IRCT 2022-01-09 Semnan University of Medical Sciences Effect of sake yeast supplementation (Saccharomyces cerevisiae) and S-adenosyl methionine (SAM) on pharmacoresistant epilepsy Investigation of effectiveness of sake yeast supplementation (Saccharomyces cerevisiae) and S-sdenosyl methionine (SAM) in pharmacoresistant epileptic patients 2022-04-03 anticipated 120 Complete https://irct.ir/trial/61029 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization will be performed. Blocking is usually used to balance the number of samples assigned to each of the groups studied. A common method is to ensure that during the process of random division, number of people between groups have been distributed equally. 4 blocks will be used. This means that in a study with 60 members, exactly 30 people are assigned to each group (treatment and control). We have two treatment (T) and placebo or control (C) groups. There are six different modes for 4 blocks: 1. TCCT 2. TCTC 3. TTCC 4. CTTC 5. CTCT 6. CCTT • We create random numbers by a computer. For numbers between 0 and 1/6 compound 1 (TCCT), numbers between 2.6 to 1.6 compound 2 (TCTC) and so on, Blinding description: Medications will be coded by a third person (outside the study) (e.g., the main treatment group number 1 and placebo group number 2). Then the stickers of the medications are removed and the drugs will be available to the student (responsible for the correct follow-up and administration of the medications). Student sees only the number and does not know the type of medicine. The patient merely knows that he/she will be given a medication that will help his/her problem and is completely unaware of the type of medication. After administering the drugs and registering the data by the student, the data will be provided to the statistical analyst (which he/she knows only the number but not the type of medication). After statistical analysis, the data will be available to the researcher responsible for writing the article. To write the article, the main researcher will also use the third person (outside the study) to match the numbers to the type of medication. 3 pharmacoresistant epilepsy. Intervention 1: Intervention group 1: Sake treatment (12 weeks). Participants who meet the inclusion criteria will be given Sake oral tablets every night for 12 weeks 30 minutes before bedtime. The treatment method will be oral and no special equipment will be used. Patients will be examined by a physician once a week, have an electroencephalogram recorded, and will deliver a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. Sake medicine is in the form of an oral tablet with a dose of 500 mg and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. Intervention 2: Intervention group 2: S-adenosyl methionine treatment (12 weeks). Participants who meet the inclusion criteria will be given S-adenosyl methionine oral tablets every night for 12 weeks 30 minutes before bedtime. The treatment method will be oral and no special equipment will be used. Patients will be examined by a physician once a week, have an electroencephalogram recorded, and will deliver a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. S-adenosyl methionine is in the form of oral tablets with a dose of 3200-1600 mg and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. Intervention 3: Control Group (placebo): Participants who meet the inclusion criteria will be given a placebo tablet every night for 12 weeks, 30 minutes before bedtime. Administration will be oral and no special equipment will be used. Patients will be examined once a week by a physician, have an electroencephalogram recorded, and will complete a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. The placebo is in the form of an oral tablet (as same as sake or S-adenosyl methionine tablets with the same shape, size and taste) and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If patient satisfaction is obtained and the data obtained from this study is useful for other studies (such as cohort), individual data will be published
public Hooman Bozorgi
Semnan , 5th kilometer of damghan road , Semnan University of Medical Sciences , pharmacology department
Semnan Iran (Islamic Republic of) 3514799442 +98 21 3344 1022 hoomanbozorgi@semums.ir Semnan University of Medical Sciences scientific Hooman Bozorgi
Semnan , 5th kilometer of Damghan road , Semnan University of Medical Sciences , Pharmacology Department
Semnan Iran (Islamic Republic of) 3514799442 0098 23 334410222 hoomanbozorgi@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pharmacoresistant epileptic patients Patients who have not responded to any of the anticonvulsant drugs on the market for at least one year no limit no limit Both 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 G40.501 Epileptic seizures related to external causes, not intractable, with status epilepticus Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Sake treatment (12 weeks). Participants who meet the inclusion criteria will be given Sake oral tablets every night for 12 weeks 30 minutes before bedtime. The treatment method will be oral and no special equipment will be used. Patients will be examined by a physician once a week, have an electroencephalogram recorded, and will deliver a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. Sake medicine is in the form of an oral tablet with a dose of 500 mg and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. Intervention group 2: S-adenosyl methionine treatment (12 weeks). Participants who meet the inclusion criteria will be given S-adenosyl methionine oral tablets every night for 12 weeks 30 minutes before bedtime. The treatment method will be oral and no special equipment will be used. Patients will be examined by a physician once a week, have an electroencephalogram recorded, and will deliver a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. S-adenosyl methionine is in the form of oral tablets with a dose of 3200-1600 mg and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. Control Group (placebo): Participants who meet the inclusion criteria will be given a placebo tablet every night for 12 weeks, 30 minutes before bedtime. Administration will be oral and no special equipment will be used. Patients will be examined once a week by a physician, have an electroencephalogram recorded, and will complete a completed questionnaire (daily seizure frequency) within one hour of consultation at the hospital. The placebo is in the form of an oral tablet (as same as sake or S-adenosyl methionine tablets with the same shape, size and taste) and is a product of Sigma-Aldrich company. The tablets are given once a day (every night 30 minutes before bedtime) orally for 12 consecutive weeks of treatment. 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. 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. Semnan University of Medical Sciences Approved 2021-12-28 Ethics committee of Semnan University of Medical Sciences and Health Services Semnan, Basij BLV, Central Department (headquarter) of Semna University of Medical Sciences and Health Services Semnan Semnan Iran (Islamic Republic of)