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The Combined Effect of Silybum marianum, Cynara scolymus, Curcuma longa and Taraxacum officinale extracts on metabolic parameters, oxidative stress biomarkers and inflammation in patients with Non-alcoholic fatty liver disease

Protocol summary

Study aim
The aim of the present study was to investigate the combined effect of Silybum marianum, Cynara scolymus, Curcuma longa and Taraxacum officinale extracts on metabolic parameters, oxidative stress biomarkers and inflammation in patients with Non-alcoholic fatty liver disease
Design
Random assignment was done by the use of computer-generated random numbers. Population and sample size: In the study 60 patients with Non-alcoholic fatty liver disease among patients of eligible and referred to Velayat hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, will be selected.
Settings and conduct
In the study 60 patients with Non-alcoholic fatty liver disease among patients of eligible and referred to Velayat hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, will be selected.
Participants/Inclusion and exclusion criteria
In this study, patients aged 30 to 70, with Non-alcoholic fatty liver disease will be included. Unwillingness to cooperate, diabetic patients, Smokers, alcoholics and consumers of nerve drugs will be excluded from the study.
Intervention groups
Patients will be assigned to receive either combined extract (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Metabolic parameters, oxidative stress biomarkers and inflammation will be measured in patients with Non-alcoholic fatty liver disease before and after of the intervention.

General information

Reason for update
Acronym
Fatty Liver
IRCT registration information
IRCT registration number: IRCT20170430033730N2
Registration date: 2018-07-02, 1397/04/11
Registration timing: registered_while_recruiting

Last update: 2018-07-02, 1397/04/11
Update count: 0
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Seyyed Mehdi Mirhashemi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
sm.mirhashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-07-19, 1397/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Combined Effect of Silybum marianum, Cynara scolymus, Curcuma longa and Taraxacum officinale extracts on metabolic parameters, oxidative stress biomarkers and inflammation in patients with Non-alcoholic fatty liver disease
Public title
The Combined Effect of Silybum marianum, Cynara scolymus, Curcuma longa and Taraxacum officinale extracts on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Non-alcoholic fatty liver disease
Exclusion criteria:
patients who do not want to cooperate People who smoke People who drink alcohol Patients with gastrointestinal disorders Patients who take nerve medications Diabetic Patients
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo was used to blind. Researchers and Patients will be blinded by the professional analyst until final analysis.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.QUMS.REC.1396.491

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
FBS
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

2

Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
TG
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

2

Description
Cholesterol
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

3

Description
HDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

4

Description
LDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

5

Description
AST
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

6

Description
ALT
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

7

Description
Glutathion
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

8

Description
MDA
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

9

Description
IL-1
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

10

Description
TNF-α
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: Two capsules of 275 mg of combined extract were taken twice daily for twelve weeks
Category
Treatment - Drugs

2

Description
Control group: Two capsules of 275 mg of placebo were taken twice a day for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peimani
Street address
Shahid Beheshti Blvd - Valiasr Square
City
Qazvin
Province
Qazvin
Postal code
34156-13911
Phone
+98 28 3333 7006
Email
a.peymani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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