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Investigating the effects of Silymarin in the treatment of idiopathic hyperbilirubinemia:a randomized,double-blind, placebo-controlled, clinical trial

Protocol summary

Study aim
Determining the effect of oral extract of silymarin in the treatment of neonatal hyperbilirubinemia
Design
Clinical trial with control and intervention groups, with parallel groups, double-blind, randomized. Random Allocation Software is used for randomization. Sample size 60 neonates, 30 in each group.
Settings and conduct
Term neonates admitted due to jaundice in NICU of Mashhad Ghaem Hospital randomly divided into two groups. One group is given 4 mg per kg of silymarin oral extract twice daily for two days from the first day of phototherapy and control group is prescribed placebo, which is distilled water, in the same amount and frequency. Serum bilirubin is measured at 6, 12, 24 and 48 hours.This is a double- blind study and parents and researchers do not know the type of drug and the drug is coded as A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy infants 2 to 10 days old with icter who meet the AAP criteria for the treatment of hyperbilirubinemia with phototherapy. Exclusion criteria: parental dissatisfaction, blood incompatibility, underlying disease
Intervention groups
In the intervention group, in addition to phototherapy, infants received 4 mg per kilogram of oral silymarin at a concentration of 4 mg per cc prepared at the Medicinal Plants Research Center of Mashhad University of Medical Sciences every 12 hours from the first day of hospitalization. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment. In the control group, placebo, which is distilled water, is prescribed in the same amount and frequency as the intervention group (one cc per kg of body weight) and serum bilirubin is measured 6, 12, 24 and 48 hours after the start of treatment.
Main outcome variables
serum bilirubin levels; duration of phototherapy; length of hospital stay

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211122053144N1
Registration date: 2022-01-02, 1400/10/12
Registration timing: prospective

Last update: 2022-01-02, 1400/10/12
Update count: 0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Sara Mohammadzadeh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 8539
Email address
mohammadzadehrs991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of Silymarin in the treatment of idiopathic hyperbilirubinemia:a randomized,double-blind, placebo-controlled, clinical trial
Public title
Investigating the effects of Silymarin in the treatment of neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonates who have the AAP criteria for the treatment of hyperbilirubinemia with phototherapy Healthy term neonates who have jaundice from the 2nd to the 10th day of birth and need phototherapy
Exclusion criteria:
Neonates with bilirubin level in range of blood exchange The neonate or mother has received phenobarbital Neonates with dehydration, sepsis, pneumonia, anemia, severe weight loss, hypoglycemia, renal failure, heart failure, possible hemolytic or inherited hemolytic disease, neonates with conjugated hyperbilirubinemia, neonates with G6PD, ABO or Rh incompatibility Neonates with a history of jaundice medication from two days before
Age
From 2 days old to 10 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple Randomization tool: closed envelope Allocation Concealment: sealed envelopes containing random and equal sequence contents from two intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which the researcher and the patient do not know about the type of drug. Drugs and placebos are exactly the same in shape, color, smell, and glass, and are codenamed A and B. After collecting the data, the codes are opened and the drug and placebo are identified
Placebo
Used
Assignment
Parallel
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
Azadi Square, east door of the university campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-09-07, 1400/06/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.467

Health conditions studied

1

Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
serum bilirubin
Timepoint
24,48 and 72 hours after starting phototherapy
Method of measurement
bilirubin kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, in addition to phototherapy, neonates receive from the first day of hospitalization at the rate of 4 mg per kg of body weight every 12 hours oral drops of silymarin with a concentration of 4 mg per cc prepared at the Medicinal Plants Research Center of Mashhad University of Medical Sciences. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment.
Category
Treatment - Drugs

2

Description
Control group: In the control group, in addition to phototherapy, infants receive an equal amount of placebo (distilled water) from the first day of hospitalization. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Ghaem hospital
Full name of responsible person
Sara Mohammadzadeh Rezaei
Street address
Dr. Shariati Square, Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2502
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Ghoreshi Building, next to Hoveyzeh cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
Sara Mohammadzadeh Rezaei
Position
Neonatology fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2502
Fax
Email
mohammadzadehrs991@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholam Ali Maamouri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatologist
Street address
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2502
Fax
Email
maamourigh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Mohammadzadeh Rezaei
Position
Neonatology fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2502
Fax
Email
mohammadzadehrs991@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 can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institute
Under which criteria data/document could be used
After publication as an article, it can be used by the public and researchers of medical universities
From where data/document is obtainable
Data can be accessible through an email to the corresponding author. Email: mohammadzadehrs991@mums.ac.ir
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
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