Protocol summary
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Study aim
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Investigating the effect of a herbal medicine on controlling the frequency of seizures
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Design
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A randomized, parallel group, double blinde, placebo controlled trial
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Settings and conduct
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This study was conducted at Neurology Clinic of Imam Hussein Hospital. Patients are referred to the clinical pharmacist by neurologist after they evaluated by a neurologist if they are qualified to enter into the study. After complete information about the study is provided to the patients, drug/placebo will be delivered to the patient if agreed. Laboratory tests will taken included
CBC, Plt, AST, ALT, Alp, BUN,
(Cr, Pt, Ptt, INR, drug levels (if applicable)
At the start of the study, and every month, up to three months. The patient's assessment will be done monthly, and the frequency of seizure and possible side effects will be documented.
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Participants/Inclusion and exclusion criteria
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Patients older than 15 years of age who have had at least 3 seizures in the last 3 months are included in the study. Patients whose seizures have no apparent symptoms or are susceptible to psychogenic epilepsy are excluded.
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Intervention groups
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Patients are divided into two groups. The first group is taking 500 mg ( of one component) of herbal medicine three times a day. The second group receives capsules of the same appearance but containing placebo. Both groups take the delivered medications for 3 months.
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Main outcome variables
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Frequency of seizure in patients; percentage of people who have had at least 50% reduction in seizure frequency; adverse effects reported by the patient
General information
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Reason for update
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Adding data related to innovation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120703010178N17
Registration date:
2019-03-05, 1397/12/14
Registration timing:
registered_while_recruiting
Last update:
2020-03-10, 1398/12/20
Update count:
1
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Registration date
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2019-03-05, 1397/12/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-06, 1397/05/15
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Expected recruitment end date
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2019-09-21, 1398/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effectiveness of a herbal product (Fenosha) as add-on therapy in uncontrolled epileptic patients: a randomized, double blinded, placebo controlled study
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Public title
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Fenosha study
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-08, 1397/07/16
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1397.122
Health conditions studied
1
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Description of health condition studied
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Epilepsy
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ICD-10 code
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G40
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ICD-10 code description
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Epilepsy and recurrent seizures
Primary outcomes
1
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Description
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Seizure frequency
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Timepoint
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30, 60, 90 days
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Method of measurement
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Patient and families's remarks
Secondary outcomes
1
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Description
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Safety and adverse drug reactions
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Timepoint
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30, 60, 90 days
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Method of measurement
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Patient's remarks
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Individual data will be shared: Demographic information, seizure frequency of each month, baseline seizure information, concomitant drugs and concomitant illnesses, reported infections.
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When the data will become available and for how long
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Staring 2 months after completion of sampling
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To whom data/document is available
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The information will be accessible to all categories by reviewing the applicant's eligibility.
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Under which criteria data/document could be used
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The sending person may include patients, legislators, researchers, university professors and students.
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From where data/document is obtainable
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Applicants must send their application along with the reason for the need for the study data to the principle investigator's email address.
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What processes are involved for a request to access data/document
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The request is evaluated within 2 weeks by the principal investigator and will be sent to the person or institution requested
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Comments
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