Protocol summary

Study aim
Assessing the effect of curcumin on reducing the number of seizures and inflammatory cytokines in patients with intractable pediatric epilepsy
Design
This study was a double-blinded, randomized, crossover clinical trial. Simple purposive sampling was used to select 22 patients with intractable epilepsy.
Settings and conduct
The patients were randomly assigned to two groups to receive placebo and curcumin in turn. Patients were given 4 mg/kg of curcumin solution (Sinacurcumin®, each drop contains 4 mg nanocurcumin) or placebo for four weeks. At the end of each course and a two week wash-out interval, the drug and placebo were replaced. the parents and the researcher were unaware of the contents of the drug containers. If the duration or number of attacks increased, the drug would be discontinued immediately.
Participants/Inclusion and exclusion criteria
Patients who were diagnosed with intractable epilepsy and aged from three months to 16 years were included in the study. Patients with a history of pseudoseizures, status epilepticus, and other dangerous diseases or those with epilepsy secondary to another progressive neurodegenerative disorder were not included in the study.
Intervention groups
Patients received either a daily dose of 4 mg/kg curcumin or placebo as an add-on therapy for four weeks. After a two week washout period, the received treatment was replaced, and the new treatment was given for another four weeks.
Main outcome variables
the number of seizure attacks, inflammatory cytokine levels (IL1, IL2, IL4, IL6, IL8, IL10, MCP1, EGF, TNF, IFN gamma)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130811014330N7
Registration date: 2019-12-26, 1398/10/05
Registration timing: retrospective

Last update: 2019-12-26, 1398/10/05
Update count: 0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
2015-07-25, 1394/05/03
Actual recruitment end date
2015-08-27, 1394/06/05
Trial completion date
2015-10-25, 1394/08/03
Scientific title
The Effect of Curcumin on Reducing the Number of Seizures and Inflammatory Cytokines in Patients with Intractable Pediatric Epilepsy
Public title
Effect of Curcumin in Treatment of Pediatric Intractable Epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 4 epileptic seizures in the last 4 weeks. Has been using anticonvulsant drugs for at least the last 1 month. The child's parents have informed consent. Not having a history of exacerbating seizures. Not having a cardiovascular, liver, or kidney disorder.
Exclusion criteria:
Diagnosing a curable cause for the epilepsy. Epilepsy is secondary to a progressive or neurodegenerative brain disorder. Having a history of status epilepsy within the past 3 months. Having multiple and uncountable seizures. Lack of cooperation in taking the medicines properly.
Age
From 3 months old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 22
Actual sample size reached: 22
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly allocated to two groups by simple randomization based on computer-generated random numbers. Sealed drug containers were used in order to conceal the treatments to the clinician and patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinician, parents, patients and the researchers were unaware of the contents of drug or placebo containers. Sealed drug containers were used in order to conceal the treatments to the clinician and patients.
Placebo
Used
Assignment
Crossover
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
Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2015-05-09, 1394/02/19
Ethics committee reference number
IR.MUMS.REC.1394.42

Health conditions studied

1

Description of health condition studied
Pediatric intractable epilepsy
ICD-10 code
G40.919
ICD-10 code description
Epilepsy, unspecified, intractable, without status epilepticus

Primary outcomes

1

Description
number of seizure attacks
Timepoint
baseline (before starting intervention), 4, 6,10 weeks after intervention
Method of measurement
based on clinical report of attacks

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group 1: Patients were given 4 mg/kg curcumin solution daily for four weeks (Sinacurcumin®, each drop of solution contains 4 mg nanocurcumin). After a two-week washout period, the drug was replaced with the placebo, and the patient received 4 mg/kg placebo for another four weeks.
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients were given 4 mg/kg placebo daily for four weeks. After a two-week washout period, the placebo was replaced with the drug, and the patient received 4 mg/kg curcumin solution (Sinacurcumin®, each drop of solution contains 4 mg nanocurcumin) for another four weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital Mashhad
Full name of responsible person
Dr. Farah Ashrafzadeh
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraishi building of MUMS, Daneshghah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3854 3031
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
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr891@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr891@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr891@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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