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Investigating the effect of L-arginine on patients with non-alcoholic fatty liver disease

Protocol summary

Study aim
Investigating the effect of L-arginine in alleviating patients with non-alcoholic fatty liver disease
Design
A clinical trial with two groups of drug intervention and placebo with parallel groups, double blind, phase 4 on 60 patients who are randomly assigned to the groups.
Settings and conduct
Patients with non-alcoholic fatty liver disease (referring to the gastroenterology clinic of Taleghani Hospital in Tehran) who were diagnosed by ultrasound will be included in the study. At the beginning of the study, all patients undergo AST, ALT, FIB-4, PLT and fibroscan tests. BMI of the patients will also be checked. Then, based on the principle of randomness, they are divided into two groups of 30 people. For the first group, lifestyle modification and L-arginine are prescribed at a dose of 2 grams per day, and for the second group, lifestyle modification and placebo are prescribed. This study will be double-blind so that the participants and the analyst are blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients over 18 years old with non-alcoholic fatty liver disease Exclusion criteria: drug complications, beginning pregnancy during the study
Intervention groups
For the first group, lifestyle modification and L-arginine (perarin pars company) at a dose of 2 grams daily, and for the second group, lifestyle modification and placebo (perarin pars company) are prescribed.
Main outcome variables
Improvement of liver steatosis, improvement of paraclinical index of ALT, improvement of Fib-4

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230409057859N1
Registration date: 2023-04-18, 1402/01/29
Registration timing: prospective

Last update: 2023-04-18, 1402/01/29
Update count: 0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Afsaneh Sharifian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2525
Email address
afsanehsharifian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of L-arginine on patients with non-alcoholic fatty liver disease
Public title
The effect of L-arginine in non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver Patients over 18 years old
Exclusion criteria:
• pregnant women • Patients with liver cirrhosis • Patients with viral and autoimmune hepatitis • Patients with advanced heart and kidney diseases • Patients with celiac disease Wilson's patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to two arms, using block randomization method. The block size is four, involving 3 patients (based on order’s coming) which would generated by online block randomization software “Sealed Envelope”. The list of random blocks will be placed in envelopes, daily would be opened by the staffs.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be single- blind, so that the analyzing researcher does not know which data is related to which patient, and the data related to the patients will be provided to him with the code, not with the name of the patient. Also, regarding the blinding of the participants, the general process of the study will be explained to them, but the patients will not know which group they will be in and which intervention (placebo or drug).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gastroenterology and Liver Research Institute of Shahid Beheshti University of M
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.SBMU.RIGLD.REC.1401.036

Health conditions studied

1

Description of health condition studied
fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Improvement of hepatic steatosis
Timepoint
before the start of the intervention and 3 months after the intervention
Method of measurement
fibro scan

2

Description
Alanine Aminotransferease (ALT) allevation
Timepoint
before the start of the intervention and 3 months after the intervention
Method of measurement
blood test- biochemical marker

3

Description
Fibrosis Index -for liver based in 4 factors (Fib-4) alleviation
Timepoint
before the start of the intervention and 3 months after the intervention
Method of measurement
Mathematical formula fib-4

Secondary outcomes

1

Description
BMI alleviation
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Height and weight ratio formula

Intervention groups

1

Description
Intervention group: The first intervention group will receive lifestyle modification and L-arginine drug (Perarin Pars Company) at a dose of 2 grams per day for 3 months.
Category
Treatment - Drugs

2

Description
Intervention group: The second intervention group will receive lifestyle modification and placebo (Perarin Pars Company) once a day for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Liver Clinic, Taleghani Hospital, Tehran
Full name of responsible person
Mohammad Javad Ehsani
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 0505
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Rashvand
Position
Gastroenterologist assistant
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
dr.h.rashvand@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Sharifian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
009891222432525
Email
afsanehsharifian@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hatami
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
bzd_hatami@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the complete presentation of the results based on the data in the text of the article, and the preservation of the raw data, there are no plans to publish it.
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study protocol and clinical study report will be made available to other researchers. Also, the statistical analysis map and the codes used in the analysis are provided to statistical experts
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers, professors and students in the field of gastroenterology
Under which criteria data/document could be used
For the purpose of use and guidance for further studies and if reference is mentioned
From where data/document is obtainable
corresponding author Hossein Rashvand dr.h.rashvand@gmail.com
What processes are involved for a request to access data/document
Sending the request email to the responsible author and mentioning the reason for the request and how to use the data
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