Comparing the effect of combined extract of Fumaria parviflora, Salix aegyptiaca, Taraxacum officinale ,Coriandrum sativum L versus Vit E on liver enzymes level in patients with fatty liver disease
The aim of the study is evaluating the effect of combined extract of Fumaria parviflora, Salix aegyptiaca, Taraxacum officinale ,Coriandrum sativum L. on fatty liver disease.This is a clinical trial study.
Inclusion criteria: AST, ALT more than 1.5 equivalents of normal range plus sonographic confirmation; from 20 to 60 years old
Exclusion criteria: Taking drugs before or at the time of intervention that could affects liver function tests; Pregnancy or breastfeeding; Younger than 20 or older than 60 years old
Target sample size: 82
We selected patients included inclusions criteria in our study(We ignored the degree of fatty liver diseases and The criterion is to improve it at any grade)
under consideration of exclusion criteria.we explained aim and method of the study at first and then patients were divided into two groups: vit E user and herbal extract user, then they used drugs(100 ML of herbal extract twice a day and 40 Mg vit E daily) for 40 days and then we tested TG, FBS, CHOL, AST, ALT and signs(right upper quadrants pain) for evaluating effect of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082935963N1
Registration date:2017-10-30, 1396/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-30, 1396/08/08
Registrant information
Name
Ehsan Sahbayi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8440
Email address
sahbayie88@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of combined extract of Fumaria parviflora, Salix aegyptiaca, Taraxacum officinale ,Coriandrum sativum L versus Vit E on liver enzymes level in patients with fatty liver disease
Public title
Effect of herbal extracts on fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
AST, ALT more than 1.5 equivalents of normal range plus sonographic confirmation; from 20 to 60 years old
Exclusion criteria :
alcoholic drinks user( now or in past); being athlete; hospitalized; Acute or chronic disease before or at the time of intervention that can affects liver function tests; Taking drugs before or at the time of intervention that could affects liver function tests; Pregnancy or breastfeeding; Younger than 20 or older than 60 years old
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:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of medical science
Street address
asadabadi street, central site of Sabzevar University of Medical Sciences
City
sabzevar
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MEDSAB.REC.1395.153
Health conditions studied
1
Description of health condition studied
fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Aminotransferases
Timepoint
1-3 days before intervention and 40 days after intervention
Method of measurement
U/L
Secondary outcomes
1
Description
Cholestrol
Timepoint
1-3 days before intervention and 40 days after the intervention
Method of measurement
Mg/dl
2
Description
Triglyceride
Timepoint
1-3 days before intervention and 40 days after the intervention
Method of measurement
Mg/dl
3
Description
Fasting blood sugar
Timepoint
1-3 days before intervention and 40 days after the intervention
Method of measurement
Mg/dl
Intervention groups
1
Description
Intervention group 1: Comparison of effectiveness of combined extract of Fumaria parviflora, Salix aegyptiaca, Taraxacum officinale ,Coriandrum sativum L. 100 ml BID
Category
Treatment - Drugs
2
Description
Intervention group 2: vit E 400 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
GI clinic of vasei sabzevar
Full name of responsible person
Street address
City
sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medicine Sciences
Full name of responsible person
research university unit
Street address
Asadabadi Street, Central Site of Sabzevar University of Medical Sciences
City
sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Sabzevar University of Medicine Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ehsan sahbayi Ejlali
Position
Intern( in medcine science)
Other areas of specialty/work
Street address
asadabadi street, central site of medical science univercity
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
e24267s@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
sabzevar medical science university
Full name of responsible person
dr.mehdi molavi
Position
GI Proficiency
Other areas of specialty/work
Street address
vasei hospital
City
sabzevar
Postal code
Phone
+51 44 651300
Fax
Email
mehdi_molavi74@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University Of Medical Sciences
Full name of responsible person
Sahbayi Ejlali Ehsan
Position
Intern (in medicine)
Other areas of specialty/work
Street address
Bahar street, Male Dormitory of Medical Sciences, Imam Reza
City
Sabzevar
Postal code
9618665959
Phone
+98 51 4466 3477
Fax
Email
e24267s@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)