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Effects of Ganoderma lucidum on laboratory change in Non alcoholic fatty liver disease patient in 12 week clinical trial

Protocol summary

Study aim
Effects of Ganoderma lucidum on laboratory change in Non alcoholic fatty liver disease patient
Design
Iَn a randomised, double-blind, controled clinical trials 80 patients will randomly assigne in the control and intervention groups.
Settings and conduct
Among patients admitted in medical ward of Kowsar hospital, Semnan who fullfil in clusion criteria,Intervention group receive 3 capsules daily containing whole powder of Ganoderma lucidum, 220 mg; pure aqueous extract of Ganoderma lucidum, 30 mg standardized based on 17 micrograms per 1 mg total polysaccharide and control group receive only reutine treatment. It is mentioned to patients that follow exercise programs and a low-fat diet. The laboratory test including CBC diff, BUN, Cr, ALT, AST, FBS will be done at the beginning of the study by the end of the twelfth week
Participants/Inclusion and exclusion criteria
Age 20 to 60 year Fatty liver in sonography ALT over40 Satisfied patient Cardiac disease Familial hyper lipidemia Over weight with bmi over 30 Acute systemic disease(renal or galblader stone) Cardiac surgery Abdomina surgery CVA Hepatitis Pancrititis Hemochromatosis Wilson’s disease Autoimmune hepatitis Chronic liver disease Surgery in past 6 month Liver or galblader surgery Weith loss in 3 past month Alcohol user Sensivity to mushroom Drug related fatty liver
Intervention groups
Intervention group receive 3 capsules daily containing whole powder of Ganoderma lucidum, 220 mg; pure aqueous extract of Ganoderma lucidum, 30 mg standardized based on 17 micrograms per 1 mg total polysaccharide. Patients in control group receive only reutine treatment.
Main outcome variables
Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), , total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high-densitylipoprotein (HDL) levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191217045763N1
Registration date: 2020-11-29, 1399/09/09
Registration timing: retrospective

Last update: 2020-11-29, 1399/09/09
Update count: 0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
Hanif Hashemnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 0373
Email address
hashemnejad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-22, 1398/11/02
Expected recruitment end date
2020-04-21, 1399/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Ganoderma lucidum on laboratory change in Non alcoholic fatty liver disease patient in 12 week clinical trial
Public title
Ganoderma lucidum in Non alcoholic fatty liver disease patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient refered to gastroentrology clinic of semnan kosar hospital Diagnose is Non alcoholic fatty liver disease Don't receive treatment yet
Exclusion criteria:
No sonographic change for fatty liver Alcoholic fatty liver Other liver disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Ave.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.SEMNAN.RES.1398.225

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
DB92
ICD-10 code description
Non-alcoholic fatty liver disease

2

Description of health condition studied
Fatty liver disease
ICD-10 code
DB92.Z
ICD-10 code description
Non-alcoholic fatty liver disease, unspecified

Primary outcomes

1

Description
Effects of Ganoderma lucidum on ALT in Non alcoholic fatty liver disease patient
Timepoint
12 week
Method of measurement
Laboratory Reference

2

Description
Effects of Ganoderma lucidum on AST in Non alcoholic fatty liver disease patient
Timepoint
12 week
Method of measurement
laboratory Reference

Secondary outcomes

1

Description
CHOLESTROL
Timepoint
12 week
Method of measurement
Laboratory reference

2

Description
LDL
Timepoint
12week
Method of measurement
Laboratory reference

3

Description
HDL
Timepoint
12 week
Method of measurement
Laboratory reference

Intervention groups

1

Description
Intervention group receive 3 capsules daily containing whole powder of Ganoderma lucidum, 220 mg; pure aqueous extract of Ganoderma lucidum, 30 mg standardized based on 17 micrograms per 1 mg total, produced by Ki Daroo Technology Company, the Ministry of Health license code 1681449932720180. It is mentioned to patients that follow exercise programs and a low-fat diet. The laboratory test including CBC diff, BUN, Cr, ALT, AST, FBS will be done at the beginning of the study by the end of the twelfth week
Category
Treatment - Drugs

2

Description
Control group: recieve reutin tratment. It is mentioned to patients that follow exercise programs and a low-fat diet. The laboratory test including CBC diff, BUN, Cr, ALT, AST, FBS will be done at the beginning of the study by the end of the twelfth week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Hanif Hashemnejad
Street address
Basij Ave
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Fax
+98 23 3142 2121
Email
kosarhos@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Reza Dabiri
Street address
Basij Ave
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
Dabirirzf@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hanif Hashemnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Basij Ave
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
Hashemnejad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hanif Hashemnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 88, Zeytoon 7th, Tohid 16th, Janbazan Bulevard
City
Babol
Province
Mazandaran
Postal code
4718766389
Phone
+98 11 5522 0373
Fax
Email
Hashemnejad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hanif Hashemnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 88, Zeytoon 7th, Tohid 16th, Janbazan Bulevard
City
Babol
Province
Mazandaran
Postal code
4718766389
Phone
+98 11 5522 0373
Fax
Email
Hashemnejad@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
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
Title and more details about the data/document
Some information
When the data will become available and for how long
6 month after article publition
To whom data/document is available
All
Under which criteria data/document could be used
With reference
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
In 15 day with my E-mail
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