Protocol summary
-
Study aim
-
The main aim of this randomized clinical trial is to evaluate the protective potential of Propolis extract on hepatic and fibrosis and steatosis among non-alcoholic fatty liver disease patients with the diagnosis of hepatic fibrosis.
-
Design
-
The current study will be a 4- month intervention with Propolis extract among non-alcoholic fatty liver disease patients with hepatic elastography-diagnosed hepatic fibrosis. The written informed consent will be obtained from patients who will participate in the study at enrollment time. Participants will be assessed for eligibility criteria in the first visit. The randomization procedure will be performed using the stratified block method. Eligible participants will randomly be assigned to one of two groups; a group received Propolis extract at a dose of 500 mg per day and a group received placebo. With the exception of Pharmacist, the treatment assignment will be concealed from the patients, care provider, investigator, outcome assessor and data analyser, and data and safety monitoring board throughout the study.
-
Settings and conduct
-
Participants will be recruited from outpatients attending gastroenterology clinic at Imam Reza hospital in Mashhad, Iran.
-
Participants/Inclusion and exclusion criteria
-
non-alcoholic fatty liver disease patients with the diagnosis of hepatic fibrosis
-
Intervention groups
-
Intervention group: Propolis extract at a dose of 500 mg per day for four consecutive months
Control group: Placebo at a dose of 500 mg per day for four consecutive months
-
Main outcome variables
-
Hepatic steatosis and fibrosis
General information
-
Reason for update
-
Information correction
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180824040857N1
Registration date:
2018-10-24, 1397/08/02
Registration timing:
registered_while_recruiting
Last update:
2020-09-19, 1399/06/29
Update count:
1
-
Registration date
-
2018-10-24, 1397/08/02
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-08-01, 1397/05/10
-
Expected recruitment end date
-
2018-10-26, 1397/08/04
-
Actual recruitment start date
-
2018-08-01, 1397/05/10
-
Actual recruitment end date
-
2018-10-26, 1397/08/04
-
Trial completion date
-
2019-02-28, 1397/12/09
-
Scientific title
-
Effect of Propolis extract on hepatic steatosis and fibrosis status in patients with non-alcoholic fatty liver disease
-
Public title
-
Effect of Propolis extract on non-alcoholic fatty liver disease
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Having evidence of fibrosis and steatosis on liver elastography
The absence of alcohol consumption
Having no secondary causes of hepatic steatosis such as hepatitis C virus, autoimmune hepatitis, haemochromatosis, hypopituitarism, hypothyroidism, Wilson’s disease, and regular use of hepatotoxic drugs (e.g., amiodarone, tamoxifen, valproate, methotrexate) or corticosteroids.
Exclusion criteria:
Pregnancy
Lactation
Having weight management program
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
54
Actual sample size reached:
54
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Stratified block randomization
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
With the exception of a pharmacist, the treatment assignment will be concealed from the patients, care provider, investigator, outcome assessor, data analyser, and data and safety monitoring board throughout the study.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-07-09, 1397/04/18
-
Ethics committee reference number
-
IR.MUMS.MEDICAL.REC.1397.121
Health conditions studied
1
-
Description of health condition studied
-
Non- alcoholic fatty liver disease (NAFLD)
-
ICD-10 code
-
K76.0
-
ICD-10 code description
-
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
-
Description
-
Hepatic steatosis
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Two-dimensional shear wave elastography (2-D SWE)
2
-
Description
-
Hepatic fibrosis
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Two-dimensional shear wave elastography (2-D SWE)
Secondary outcomes
1
-
Description
-
Alanine aminotransferase (ALT)
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
2
-
Description
-
Aspartate aminotransferase (AST)
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
3
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
4
-
Description
-
LDL
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
5
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
6
-
Description
-
TG
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
7
-
Description
-
fasting blood sugar (FBS)
-
Timepoint
-
At the beginning of the study and the fourth month of the intervention
-
Method of measurement
-
Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran)
Intervention groups
1
-
Description
-
Intervention group: Propolis extract at a dose of 500 mg per day for four consecutive months
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group:Placebo at a dose of 500 mg per day for four consecutive months
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
-
When the data will become available and for how long
-
The non-identifiable individual participant data will become available after the publication of the relevant articles.
-
To whom data/document is available
-
The non-identifiable individual participant data will become available to other researchers in academic institutions.
-
Under which criteria data/document could be used
-
The non-identifiable individual participant data can only be used for research.
-
From where data/document is obtainable
-
The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Mohsen Nematy. ( e-mail address: NematyM@mums.ac.ir)
-
What processes are involved for a request to access data/document
-
Other researchers in academic institutions can send their request by e-mail to Dr. Mohsen Nematy. The data will be sent to them after consulting and approving the research team.
-
Comments
-