The effect of hydroalcoholic extract of Berberis fruits integerrima on the lipid profile, antioxidantparameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease
Evaluation of the Barberry fruits effects on patient with Non-alcoholic fatty liver disease
Design
The present randomized double-blind clinical trial study was conducted on nonalcoholic fatty liver patients who referred to Ali-Ebn-Abitaleb Rafsanjan University Hospital and their disease were confirmed with the increased liver enzymes and ultrasound of the liver tissue by an expert physician. 42 patients separated to two groups, randomly using table of random number: control group and case group
Settings and conduct
The present double-blind clinical trial was performed on NAFLD patients who referred to Ali-Ebn-Abitaleb Rafsanjan Hospital. Control group received cellulose, case group received hydro-alcoholic extract of Berberis. Patients, care provider and data analyzer were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from nonalcoholic fatty liver; elevated levels of AST, ALT; the age range of 20-45 years and the signing a declaration of consent. Patients using alcohol, daily berberis and having allergy to berberis and its compounds; patients with diabetes; high blood pressure; perceptual disorders; nephrotic syndrome; ischemic heart diseases; chronic liver disease such as hepatitis, and pregnancy and lactation were excluded from the study.
Intervention groups
Control group received a gelatin capsule contain 750 mg cellulose; case group received a gelatin capsule contain 750 mg hydro-alcoholic extract of Berberis integerrima every 12 hours for two months.
Main outcome variables
Biochemical factors; functional liver and renal test; antioxidant parameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044196N1
Registration date:2019-07-31, 1398/05/09
Registration timing:retrospective
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Mehdi Afshari nasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5900
Email address
mehdi.af.1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
2017-10-17, 1396/07/25
Actual recruitment end date
2018-12-11, 1397/09/20
Trial completion date
2019-01-15, 1397/10/25
Scientific title
The effect of hydroalcoholic extract of Berberis fruits integerrima on the lipid profile, antioxidantparameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease
Public title
The effect of hydroalcoholic extract of Berberis fruits integerrima on the lipid profile, antioxidantparameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from nonalcoholic fatty liver
Elevated levels of Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Age range of 20-45 years old
Signing a declaration of consent
Exclusion criteria:
Using alcohol
Using daily berberis
Having allergy to berberis and its compounds,
Patients with diabetes
High blood pressure
Patient with perceptual disorders
Nephrotic syndrome
Ischemic heart diseases
Patient with chronic liver disease such as hepatitis
Pregnancy or lactation
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
42
Actual sample size reached:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Patients separated to two groups, randomly using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant (patients), care provider and data analyser have no information about the type of treatment substance
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Council of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Department of Biochemistry
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
IR.RUMS.REC.1396.110
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
2
Description
total cholesterol
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
3
Description
triglyceride
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
4
Description
LDL-C
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
5
Description
HDL-C
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
6
Description
Alanine aminotransferase
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
7
Description
Aspartate aminotransferase
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
8
Description
Alkaline phosphatase
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
9
Description
total bilirubin
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
10
Description
and direct bilirubin
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
11
Description
urea
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
12
Description
creatinine
Timepoint
Before and after treatment
Method of measurement
measured using Pars azmun kit
13
Description
glutathione peroxidase enzyme
Timepoint
Before and after treatment
Method of measurement
ZellBio kit
14
Description
malondialdehyde
Timepoint
Before and after treatment
Method of measurement
ZellBio kit
15
Description
total antioxidant
Timepoint
Before and after treatment
Method of measurement
ZellBio kit
16
Description
blood pressure
Timepoint
Before and after treatment
Method of measurement
Blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: received a gelatin capsule contain 750 mg hydro-alcoholic extract of Berberis integerrima . Berberis fruits were taken from mountainous areas of Bardsir, Kerman, Southeast of Iran and confirmed by Iranian institute of research & development in chemical industries and they were extracted in that institute.
Category
Treatment - Other
2
Description
Control group: received a gelatin capsule contain 750 mg cellulose every 12 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn-Abitaleb Rafsanjan University Hospital
Full name of responsible person
Mehdi Afshari
Street address
Rafsanjan University of medical science, Department of Biochemistry
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Phone
+98 34 3131 5175
Email
mehdi.af.1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zare
Street address
Rafsanjan University of medical science, Department of biochemistry
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Phone
+98 34 3131 5175
Email
mehdi.af.1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mehdi Afshari
Position
Ms.c student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Phone
+98 34 3131 5175
Email
mehdi.af.1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mehdi Afsahri
Position
MS.c student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Phone
+98 34 3131 5175
Email
mehdi.af.1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mehdi Afshari nasab
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718134567
Phone
+98 34 3428 5900
Fax
Email
mehdi.af.1372@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
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
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