Comparison of the effect of silymarin and placebo on serum liver enzyme level in trauma patients with increased liver enzyme level in the Intensive Care Unit.
This study will be conducted in the ICU of Rajaee hospital, Shiraz, Iran. Trauma patients who have elevated liver enzymes will be categorized into two groups by permuted block randomization: 1. Receiving livergol 2- Receiving Placebo. Every patient will be determined by a number and the list of numbers of patients in each group will be given to the nurses. The participants, the physicians, the nvestigator and the data collectors will be blinded to the study.
Participants/Inclusion and exclusion criteria
Input criteria include:
People aged 16 or over
Not taking a known hepatotoxic drug Silymarin
Not taking oral silymarin during the past day
No confirmed history of allergic reactions following oral administration of silymarin
Increased ALT and AST levels
Not taking concomitant antioxidants or compounds such as vitamin A, C, E and N-acetyl cysteine.
Oral tolerance to medications
Exclusion criteria :
Pregnancy or lactation
History of advanced liver disease
Intervention groups
Treatment group: Trauma patients in intensive care units with elevated liver enzymes who receive silymarin.
Control group: Trauma patients in intensive care units with elevated liver enzymes who receive placebo.
Main outcome variables
Liver enzyme levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044744N1
Registration date:2019-09-22, 1398/06/31
Registration timing:prospective
Last update:2019-09-22, 1398/06/31
Update count:0
Registration date
2019-09-22, 1398/06/31
Registrant information
Name
Ehsan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 5885
Email address
ehsan.mirzaei.1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-11, 1398/07/19
Expected recruitment end date
2020-05-08, 1399/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of silymarin and placebo on serum liver enzyme level in patients with trauma in the Intensive Care Unit in Rajaei hospital
Public title
The effect of silymarin on serum liver enzyme level in patients with trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 16 or over
Not taking a known hepatotoxic drug
Not taking oral silymarin during the past day
No confirmed history of allergic reactions following oral administration of silymarin
Alanine aminotransferase (ALT) levels more than 2-fold above normal (> 70 IU / L) up to 4-fold above normal Or aspartate aminotransferase (AST) levels more than 2-fold above normal (> 70 IU / L) up to 4-fold above normal
Not taking concomitant antioxidants or compounds such as vitamin A, C, E and N-acetyl cysteine
Oral tolerance to medications
Exclusion criteria:
Pregnancy or lactation
History of advanced liver disease
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Permuted block randomization.
The patients are divided into 18-person groups. Using the statistical software, 9 out of 18 patients are randomly assigned to treatment group and 9 to placebo group.
Unit of randomization: Individual.
Tools used in randomization: computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug or placebo , are determined by numbers and these numbers are given to the head nurse and nurses of the ICU.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz school of pharmacy, Karafarin street, Roknabad Town
City
Shiraz
Province
Fars
Postal code
71468 64685
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.SUMS.REC.1398.768
Health conditions studied
1
Description of health condition studied
Liver Trauma
ICD-10 code
S36.112
ICD-10 code description
Contusion of liver
Primary outcomes
1
Description
Decreased liver enzyme levels
Timepoint
Start of study, end of first week, end of second week
Method of measurement
Blood test
2
Description
Measurement of free radicals
Timepoint
The beginning and the end of the study
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving Livergol tablet 140 mg Goldaru factory orally every eight hours for 14 days yo reduce liver enzyme levels
Category
Treatment - Drugs
2
Description
Control group: Receiving placebo witch was Prepared in pharmaceutical laboratory of Shiraz School of Pharmacy in similar to livergol tablet in size and color orally every eight hours for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Afsaneh Vazin
Street address
Shiraz school of pharmacy, Karafarin street, Roknabad Town
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98 71 3242 4127
Email
Vazeena@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Clinical pharmacy
Street address
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98 71 3242 4127
Email
ehsan.mirzaei.1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Clinical pharmacy
Street address
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98 71 3242 4127
Email
ehsan.mirzaei.1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Clinical pharmacy
Street address
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98 71 3242 4127
Email
ehsan.mirzaei.1369@gmail.com
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