The aim of this study is to evaluate herbal drug on intractable seizures in children. This study is conducted in children neurologic department in an academic hospital. In a clinical trial, after ethical approval and obtaining written informed consent from children parents, 44 children who are referred to pediatrics neurology clinic with intractable seizures, are entered the study based on inclusion and exclusion criteria. Inclusion criteria are included age between 4 and 15 years,drug resistant epilepsy (DRE) and written informed consent from children parents. Exclusion criteria are included pseudoseizure, neurodegenerative disease, chronic diseases.There is no control group. Herbal drug is a capsule which contained Paeoniae Radix, Anacyclus pyrethrum and Citrus aurantium L. var. amara. Children are observed closely 3 months before herbal drug administration. They receive 250 mg single dose capsule for 13 weeks. Attacks frequency and duration are recorded. Complete blood cell count (CBC) and liver function tests (LFT) are performed for all children at the end of the third month and they are control for probable side effects and complication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091515790N2
Registration date:2016-10-10, 1395/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Mehrzad Mehrbani
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 218877352125
Email address
mzmehrbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research affairs of Mashhad University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of herbal drug in the treatment of children with intractable epilepsy
Public title
Efficacy of herbal drug in the treatment of children with intractable epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Children aged between 4 and 15 years.
- Drug resistant epilepsy (DRE)
- Written informed consent from children parents
Exclusion criteria:
- Chronic diseases (such as diabetes mellitus, thyroid dysfunction, and heart, liver or kidney diseases)
- Pseudoseizure
- Neurodegenerative disease
Age
From 4 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Postal code
Approval date
2013-04-04, 1392/01/15
Ethics committee reference number
Ir.mums.res.1392.911259161
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Primary outcomes
1
Description
frequency of seizure
Timepoint
At first and three mounths after intervention
Method of measurement
counting
2
Description
intensity of seizure
Timepoint
At first and three mounths after intervention
Method of measurement
Asking from parents
Secondary outcomes
1
Description
Drug reaction
Timepoint
At the end of the 3-month intervention period
Method of measurement
Questionnaire
Intervention groups
1
Description
Patients receive 250 mg single dose capsule (contained Anacyclus pyrethrum, Paeonia officinalis and Citrus aurantium varamara) for the three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology clinic of Qaem hospital
Full name of responsible person
Seyedebrahim Mansoorinejad
Street address
Daneshgah Ave.
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for research affairs of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah street
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for research affairs of Mashhad University of Medical Sciences