Determining the effect of liverpower capsules on improving liver function in patients with fatty liver compared to placbo
Design
80 participants (no=40 per group) are randomly assigned to intervention and placebo group using random digit table
Settings and conduct
This double blinded study will be performed in Fayaz Bakhsh Hospital. At base line and after 12 weeks of intervention with supplement/placebo, liver function tests (ALT, AST, ALK-Ph) and lipid profile (T.Chol, LDL-c, HDL-c, TG) will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Liver function enzymes higher than normal level, Fatty liver diagnosis based on sonography, Age>18 years Willing to participate in the study
Exclusion criteria: having known kidney disease, having known heart disease,
pregnancy or lactation
Intervention groups
Patients will receive 500 mg liverpower capsule or placebo three times daily for 12 weeks. Each capsule contains Silybum marianum, Cichorium intybus L, Solanum nigrum and Urtica dioic extract or maltodextrine in placebo group.
Main outcome variables
Liver function tests (ALT, AST, ALK-Ph)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140804018677N11
Registration date:2021-08-09, 1400/05/18
Registration timing:registered_while_recruiting
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2022-01-09, 1400/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of liverpower supplement on liver function in patients with fatty liver comparing to placebo
Public title
Effect of liverpower on liver function in fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Liver function enzymes higher than normal level
Fatty liver diagnosis based on sonography
Age>18 years
Willing to participate in the study
Exclusion criteria:
Having known kidney disease
Having known heart disease
Pregnancy or lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomize the patients. For randomization, we will visit the www.sealedenvelope.com and use randomization tab to make a list considering the number of intervention groups, sample size, block size ( 4 is selected for current study). The prepared list that contains the pattern of patient allocation will be obtained and used. This site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 80 patients (40 patients in the intervention group (A) and 40 patients in the control group (B)), 20 blocks with a volume of four includes two groups A and B will be randomly selected using the software, such as (ABAB) ، (BBAB)، (AABB)، (ABBA)، (BAAB ......( Then 80pockets (40 pockets containing paper containing A and 40 pockets containing B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. After admission of each patient will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double blind study. A third person out of study team (clinic secretary) have the sequence of codes that provide the team with sealed pockets coded as A or B at the time of sampling. The following groups of people involved in the trial: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. After analyzing the data investigators and outcome assessors will be unblinded about A and B group allocation to supplement and placebo. Patients in supplement and placebo groups will receive packages of similar capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1305
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
Alanine Aminotransferase (ALT) enzyme
Timepoint
Baseline and at the end of the study
Method of measurement
Biochemical kits
2
Description
Aspartate transaminase (AST) enzyme
Timepoint
Baseline and at the end of the study
Method of measurement
Biochemical kits
3
Description
Alkaline phosphatase (Alk-ph) enzyme
Timepoint
Baseline and at the end of the study
Method of measurement
Biochemical kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: liverpower (500 mg), Ghaem darou company, three times daily for12 weeks
Category
Treatment - Other
2
Description
Control group: Placebo contain maltodextrine, (500 mg), Ghaem darou company, three times daily for12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayaz Bakhsh Hospital
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
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
Soodeh Razeghi Jahromi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619537
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619537
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data would be available to public
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
To all
Under which criteria data/document could be used
No other critaria
From where data/document is obtainable
Email to soodehrazeghi@gmail.com
What processes are involved for a request to access data/document