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IRCT20120703010178N17 IRCT 2019-03-05 Shahid Beheshti University of Medical Sciences Fenosha study Evaluating the effectiveness of a herbal product (Fenosha) as add-on therapy in uncontrolled epileptic patients: a randomized, double blinded, placebo controlled study 2018-08-06 anticipated 60 Complete https://irct.ir/trial/36659 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization was done by block randomization method using a randomization table made with statistical software with four blocks and individual randomization unit. To hide this table, there is only one copy of this table without specifying the study groups that are maintained by the study host in the center, Blinding description: In this study, due to the use of capsules of similar weight and appearance and similar drug canisters, drugs and placebo can not be distinguished from each other. Medications are given with three-character codes, including two letters and one number. A neurologist who introduces the patient to the study does not know what drug will be deliver to the patient. Due to the fact that it is not included in the randomization list of the study groups, the drug deliverer is blind to the delivered drug and, given the very similar appearance of the drug and the placebo, there is no way to determine the type of drug delivery for the patient and the investigator. The assessor is a self-delivering scholar who does not know the patient group. Only one person outside the study has a list of groups for each group, which only provides the original researcher if there is a report of serious side effect or the completion of study. 3 Epilepsy. Intervention 1: Intervention group: Fenosha group (herbal product) It contains two gums called dorema ammoniacum and ferula persica, mixed in capsules with a ratio of 70 to 30 to a final weight of 500 milligrams. Capsules are packed in cans in a packet of 90. This oral capsule is given three times a day for 3 months to patients and provided by Afkar-e Talaee Pharmaceutical and Industrial institute by registration ID of 43624. This product has invention certificate with below specification: owner: Reza Mazloom-Farsibaf, inventors: Reza Mazloom-Farsibaf with national ID of 0930792998 and email address of: rezamfb1978@gmail.com and Arshia Mazloom-Farsibaf with national ID of 0926044796 and email address of: rezamf1978@gmail.com, invention name: herbal product for treatment of seizure and epilepsy and international category: A61B. Intervention 2: Control group: placebo Includes capsules with a completely similar appearance and the same weight filled with lactose powder in a package of the same appearance and number, given three times a day for 3 months. Placebo capsules are also provided by Afkar-e Talaee Pharmaceutical and Industrial institute by registration ID of 43624. Yes - There is a plan to make this available What will be shared: Individual data will be shared: Demographic information, seizure frequency of each month, baseline seizure information, concomitant drugs and concomitant illnesses, reported infections. When: Staring 2 months after completion of sampling To whom: The information will be accessible to all categories by reviewing the applicant's eligibility. Conditions: The sending person may include patients, legislators, researchers, university professors and students. Where to obtain: Applicants must send their application along with the reason for the need for the study data to the principle investigator's email address. How to obtain: The request is evaluated within 2 weeks by the principal investigator and will be sent to the person or institution requested Comments:
public Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age older than 15 years old Take one or two anti-epileptic drugs at least 2 months before entering the study At least 1 seizure per month for 3 consecutive months Patient agrees to enter the study 18 years no limit Both Simple partial epilepsy without motor symptoms Known and progressive neurological disorder Status or cluster epilepsy within 3 months before entering the study History of psychogenic epilepsy in the last 2 years Uncontrolled illness or drug use associated with impaired Lab data (liver enzyme at least twice upper limit of normal or Creatinine clearance less than 50 ml / min) Non compliance Pregnancy or breastfeeding G40 Epilepsy and recurrent seizures Treatment - Drugs Placebo Intervention group: Fenosha group (herbal product) It contains two gums called dorema ammoniacum and ferula persica, mixed in capsules with a ratio of 70 to 30 to a final weight of 500 milligrams. Capsules are packed in cans in a packet of 90. This oral capsule is given three times a day for 3 months to patients and provided by Afkar-e Talaee Pharmaceutical and Industrial institute by registration ID of 43624. This product has invention certificate with below specification: owner: Reza Mazloom-Farsibaf, inventors: Reza Mazloom-Farsibaf with national ID of 0930792998 and email address of: rezamfb1978@gmail.com and Arshia Mazloom-Farsibaf with national ID of 0926044796 and email address of: rezamf1978@gmail.com, invention name: herbal product for treatment of seizure and epilepsy and international category: A61B Control group: placebo Includes capsules with a completely similar appearance and the same weight filled with lactose powder in a package of the same appearance and number, given three times a day for 3 months. Placebo capsules are also provided by Afkar-e Talaee Pharmaceutical and Industrial institute by registration ID of 43624 Seizure frequency. Timepoint: 30, 60, 90 days. Method of measurement: Patient and families's remarks. Safety and adverse drug reactions. Timepoint: 30, 60, 90 days. Method of measurement: Patient's remarks. Shahid Beheshti University of Medical Sciences Approved 2018-10-08 Shahid Beheshti University of Medical Sciences Velenjak Street, Shahid Chamran High Way Tehran Tehran Iran (Islamic Republic of)