Evaluation of the efficacy and safety of oral L-carnitine in improving liver function in liver injury
Design
A randomized, placebo-controlled, double-blinded, parallel phase 3 clinical trial
Settings and conduct
In this phase 3 randomized double-blind placebo-controlled clinical trial, 100 eligible patients admitted to Baqiyatullah Hospital, who have obtained free and informed consent, will participate in the study.
Patients will be randomly assigned to intervention and control groups with a ratio of 1:1 and will receive the desired intervention. Each patient will be in the study for 5 days.
For the purpose of blinding, a placebo with a completely similar appearance was prepared by the drug manufacturer (Bonyan Salamat Kasra).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient must be over 18 years old; The patient's Child-Pugh score is category B and C; The patient or his / her companion has informed and free written consent to participate in the study.
Exclusion criteria:
Pregnancy; Breastfeeding; History of previous allergies to any of the active ingredients of the drug; Concomitant presence in another clinical study;
Intervention groups
Intervention group: oral vial L-carnitine 2gr, 1 oral vial, every 12 hours, for 5 days.
Placebo group: oral vial Placebo 2gr, 1 oral vial, every 12 hours, for 5 days.
Main outcome variables
Changes in serum level of ALT enzyme;
Changes in serum level of AST enzyme;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N69
Registration date:2022-09-16, 1401/06/25
Registration timing:prospective
Last update:2022-09-16, 1401/06/25
Update count:0
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of L-carnitine in improving liver function in liver injury
Public title
Evaluation of the efficacy and safety of L-carnitine in improving liver function in liver injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have read and signed a written informed consent to participate in the study
Age between 18-90 years old;
The patient's Child-Pugh score is category B or C;
Exclusion criteria:
Pregnancy;
Breastfeeding;
Participate in another clinical trial at the same time;
History of previous allergies to any of the components of the drug;
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The Block Randomization method is used to randomize the patients.
For randomization, we visited www.sealedenvelope.com, then the randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo looks the same as the original drug, provided by the drug company.
In this study, the prescribing physician, patient, therapeutic team, and statistical analyzer are unaware of the type of intervention (intervention/placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah Hospital
Street address
Baqiyatallah Hospital, Sheykh-e-Baha'ee, Sare Mollasadra
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.BMSU.BAQ.REC.1400.074
Health conditions studied
1
Description of health condition studied
Diseases of liver
ICD-10 code
K76.9
ICD-10 code description
Liver disease, unspecified
Primary outcomes
1
Description
AST serum level
Timepoint
Before and after intervention
Method of measurement
Blood sample
2
Description
ALT serum level
Timepoint
Before and after intervention
Method of measurement
Blood sample
Secondary outcomes
1
Description
Bilirubin serum level
Timepoint
Before and after the intervention
Method of measurement
Blood sample
2
Description
Child-Pugh score
Timepoint
Before and after the intervention
Method of measurement
Child-Pugh score classification
Intervention groups
1
Description
Intervention group: L-carnitine oral vial containing 2 grams of L-carnitine drug, 1 orally every 12 hours, for 5 days. This drug is produced by the Bonyan Salamat Kasari pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: oral vial placebo 2gr, every 12 hours one oral vial, for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Fax
+98 21 8245 5393
Email
yunespanahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bonyan Salamat Kasra pharmaceutical company
Full name of responsible person
Ahmad Fazeli
Street address
597plaque, Hedarkhani intersection, Farjam street , Resalat square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 7709 4810
Email
Mahboubi1357@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bonyan Salamat Kasra pharmaceutical company
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zarei Abarghouee
Street address
Baqiyatallah University of Medical Science, Mollasadra Ave., Vanak
City
tehran
Province
Tehran
Postal code
193955487
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
80
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
Tehran University of Medical Sciences
Full name of responsible person
parisa kianpour
Position
Fellowship in Critical care Pharmacotherapy
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 64120
Fax
Email
Parisa_kianpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Critical care pharmacotherapy
Street address
Mollasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8821 1524
Fax
+98 21 8821 1524
Email
yunespanahi@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Zahra Khosravi
Position
pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Mollasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
parisa_kianpour@yahoo.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