Effects of herbal products Favanya (Paeonia) on intractable epilepsy in children
Design
In a pilot-controlled clinical trial, 30 children with resistant epilepsy referring to the pediatric neurology clinic, who are eligible for inclusion criteria, are included in the study.
Settings and conduct
After referring the patients from the Pediatric Neurology Clinic of Ghaem Hospital, and signing the a written informed consent, patients will receive the Paeonia herbal product with the Common medicine drugs for one month.
Participants/Inclusion and exclusion criteria
Entry Criteria: Age range 1 year to 14 years,true drug resistant epilepsy, informed consent from parents
Exclusion criteria: presence of chronic disease, history of false seizures, degenerative nerve disease
Intervention groups
Intervention group: paoenia recipient group
Main outcome variables
The number of seizures ؛ Seizure severity
General information
Reason for update
Acronym
Paeonia RCT
IRCT registration information
IRCT registration number:IRCT20131125015533N2
Registration date:2018-12-06, 1397/09/15
Registration timing:registered_while_recruiting
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Mohammadreza Noras
Name of organization / entity
Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
norasmr901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal products Paeonia on the Treatment of children with refractory epilepsy
Public title
Favanya effect on intractable epilepsy in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
true drug-resistant epilepsy
Age range 1 to 14 years
Conscious written consent from parents
Exclusion criteria:
Presence of degenerative nerve disease
History of false seizures
The presence of chronic disease
Age
From 1 year old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
University Street, Quraishi Building,
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.Mums.REC.1397.159
Health conditions studied
1
Description of health condition studied
Intractable epilepsy in children
ICD-10 code
G40
ICD-10 code description
Attack with loss of consciousness
Primary outcomes
1
Description
Number of epileptic seizures; severity of epilepsy
Timepoint
At the beginning of the study, 7, 14, 21 and 28 days later
Method of measurement
questionnaire
Secondary outcomes
1
Description
side effects
Timepoint
7, 14, 21 and 28 days after taking the drug
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Administration of paeonia officinalis hydroalcoholic extract as an oral solution of 20 mg / kg three times a day for four weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Neurology Clinic of Ghaem Hospital in Mashhad
Full name of responsible person
Mehran Beiragi Tusi
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3842 0818
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghghodi piadeh gheibi
Street address
Mashhad University of Medical Sciences, Mashhad University of Medical Sciences, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad zangoueipourfard
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.347 seyyed razi st. mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177173415
Phone
+98 51 3606 1446
Email
zangoueipm941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Noras
Position
Educational deputy of the Faculty of Traditional Medicine and Mashhad Supplement
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Comprehensive Medicine, Mashhad, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Fax
+98 51 3882 9279
Email
norasmr901@mums.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Zangoueipourfard
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.347 seyyedrazy 28
City
Mashhad
Province
Razavi Khorasan
Postal code
9177173415
Phone
+98 51 3606 1446
Email
zangoueipm941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be released after unrecognizable individuals after the end of the study.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers at universities and institutes
Under which criteria data/document could be used
In order to use the scientific results of the study in the treatment of patients, provided that the results of the study are significant.
From where data/document is obtainable
Applicants will send their request to the email address zangoueipm941@mums.ac.ir.
What processes are involved for a request to access data/document
After reviewing the application, the documentation will be sent within one month.