This is a Single-Blinded interventional study, in which children aged under 15 with a diagnosis of acute lymphoblastic leukemia undergoing induction therapy, randomly treated with Silybum marianum and Placebo with a mean dose of 5 mg/kg daily for 28 days. Patients with liver diseases or diabetes were not involved. Laboratory tests were done in patients on days 0, 28 and 56 and results were recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080717325N2
Registration date:2014-08-27, 1393/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-27, 1393/06/05
Registrant information
Name
Afshin Fathi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1226 1610
Email address
a.fathi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-21, 1392/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Silybum marianum in treatment and prevention of hepatotoxicity in patients undergoing induction therapy for acute lymphoblastic leukemia
Public title
Silybum marianum in treatment and prevention of hepatotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children aged under 15 with a diagnosis of acute lymphoblastic leukemia undergoing induction therapy Exclusion criteria: Patients with liver diseases or diabetes
Age
From 30 days old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St, Janbazan Sq
City
Ardabil
Postal code
Approval date
2013-01-20, 1391/11/01
Ethics committee reference number
Arums1032
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
Primary outcomes
1
Description
Reduces hepatotoxicity of chemotherapy
Timepoint
In first visit, Day 28, Day 56
Method of measurement
Enzymatic
Secondary outcomes
1
Description
Fasting blood glucose
Timepoint
In first visit, Day 28, Day 56
Method of measurement
In first visit, Day 28, Day 56
2
Description
Side effects
Timepoint
In first visit, Day 28, Day 56
Method of measurement
In first visit, Day 28, Day 56
Intervention groups
1
Description
Silybum marianum 5 mg/kg daily for 28 day in case group
Category
Prevention
2
Description
Zinc sulfate 5 mg/kg daily for 28 day in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu - Ali Hospital
Full name of responsible person
Dr. Afshin Fathi
Street address
Varzesh Sq. Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvane Naftchi
Street address
Daneshgah St, Janbazan Sq
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
ZhalehRoohzendeh
Position
M.D, Physician
Other areas of specialty/work
Street address
Fatemiyeh dormitory, Felestin St
City
Ardabil
Postal code
Phone
+98 45 3351 3228
Fax
Email
zhalehroohzendeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Fathi
Position
Chairman, Specialist
Other areas of specialty/work
Street address
Bu - Ali Hospital, Varzesh Sq
City
Ardabil
Postal code
Phone
+98 45 3325 2251
Fax
Email
a.fathi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
ZhalehRoohzendeh
Position
M.D, Physician
Other areas of specialty/work
Street address
Fatemiyeh dormitory, Felestin St
City
Ardabil
Postal code
Phone
+98 45 3351 3228
Fax
Email
zhalehroohzendeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)