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A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver - a single-blind randomized clinical trial

Protocol summary

Study aim
A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver
Design
This is a randomized clinical trial that will be conducted as a parallel design and single-blinded; phases 2-3 will be conducted on 90 patients with non-alcoholic fatty liver disease. Random permutation blocks are used for randomization, and participants are assigned to three intervention groups.
Settings and conduct
This study, which will be conducted at Imam Khomeini Hospital of Kermanshah, is single-blinded. Patients will be kept blinded to the type of drug they receive. At the beginning of the study, liver ultrasound and fasting blood samples are performed for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Patients with fatty liver; High liver enzymes AST, ALT Exclusion criteria: Pregnancy or breastfeeding; being an alcoholic; History of biliary diseases, heart and blood vessels, liver diseases, kidney failure and bleeding peptic ulcer, types of cancer, thyroid
Intervention groups
In the first intervention group, 1000 mg metformin tablets and 400 units of vitamin E capsules (pharmaceutical company...) are prescribed daily for 12 month. In the second intervention group, two tablets (250 mg) of Zinogan capsules(Dorset Home Company) along with 1000 mg metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month. In the third intervention group, three tablets (900 units) of Algomed chlorella algae tablets along (Steinberg Bioproduct Company) with 1000 mg of metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.
Main outcome variables
Liver enzymes (AST, ALT, ALP), Tri glyceride, Total cholesterol, Plasma insulin levels, Blood sugar, Bilirubin, Antioxidant level in blood serum, Serum albumin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221018056221N1
Registration date: 2023-01-18, 1401/10/28
Registration timing: registered_while_recruiting

Last update: 2023-01-18, 1401/10/28
Update count: 0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Mohammad Bagher Majnooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6471
Email address
mb.majnooni64@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver - a single-blind randomized clinical trial
Public title
A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Patients with fatty liver (grade 1-3) High liver enzymes AST, ALT (more than 4-35 IU/L)
Exclusion criteria:
Pregnancy or breastfeeding being an alcoholic History of biliary diseases, heart and blood vessels, liver diseases, kidney failure and bleeding peptic ulcer, types of cancer, thyroid The presence of gastrointestinal ulcers Taking any herbal supplements and vitamins
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization will be done by the method of random permutation blocks using PASS 2011 software. In this way, using PASS 2011 software, in 15 permutation blocks, six members of the letters α β γ representing each of the treatment groups (for example αβγγβα) will be created by someone outside the research plan and will be placed in envelopes, then one of the envelopes will be randomly selected, and the task of the appointed groups of 6 people who will enter the study will be determined. This will continue until the full assignment of 90 patients to 3 study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst was kept blinded to the study group allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.KUMS.MED.REC.1401.124

Health conditions studied

1

Description of health condition studied
non alcohlic fatty liver disease
ICD-10 code
K76
ICD-10 code description
Other diseases of liver

Primary outcomes

1

Description
Liver enzymes (AST, ALT, ALP)
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

2

Description
Tri glyceride
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

3

Description
Total cholesterol
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

4

Description
Plasma insulin levels
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

5

Description
Blood sugar
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

6

Description
Bilirubin
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

7

Description
Antioxidant level in blood serum
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

8

Description
Serum albumin
Timepoint
The beginning of the study and the end of the twelfth week
Method of measurement
Using a blood test

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, 1000 mg metformin tablets and 400 units of vitamin E capsules (pharmaceutical company...) are prescribed daily for 12 month.
Category
Treatment - Drugs

2

Description
In the second intervention group, two tablets (250 mg) of Zinogan capsules(Dorset Home Company) along with 1000 mg metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.
Category
Treatment - Drugs

3

Description
In the third intervention group, three tablets (900 units) of Algomed chlorella algae tablets along (Steinberg Bioproduct Company) with 1000 mg of metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Shahab Bazvandi
Street address
Imam Khomeini Hospital, Naghliyeh street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
Bazvandishahab19@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shahab Bazvandi
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
Bazvandishahab19@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. touraj Ahmadi Jouybari
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
Dr.ahmadi_jouybari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shahab Bazvandi
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
+98 83 3427 4618
Phone
+98 83 3427 4618
Email
Bazvandishahab19@gmail.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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