Protocol summary

Summary
Fatty liver is a problem that is seen in 2 percent of the general population and 20% of liver biopsies that are prepared for various causes. Today, different treatment ways are used in patients with fatty liver, some of which, such as metformin, is elected according to the nature of pathophysiological conditions associated with metabolic syndrome, and others like ursodeoxy colic acid (ursodiol) with the aim of removing of accumulating fat from liver. Meanwhile, some medications, such as vitamins and herbal medicines due to their antioxidant properties are considered for therapy. One of the herbal remedies based on traditional medicine may be effective in treating fatty liver, is extract of squill that due to the antioxidant and anti-inflammatory properties may be effective as a supplement.in traditional iranian medicine (TIM),squill (drimia maritima) oxymel was utilized in the treatment of liver disease.Accordingly, it was decided in this study to evaluate the effectiveness of squill syrup be addressed in the treatment of fatty liver In this study, which is done as a placebo controlled trial ,150 patients with fatty liver were selected that refer to Hospital Baqiyatallah in 1395. After filling out a written consent, the patients randomly divided to two groups of 75, receiving placebo syrup or squill syrup and treated for two months. Meanwhile the patients under study,take routine drugs included metformin 500 (twice a day) and vitamin E (at a rate of 800 iu / day) too. both intervention and control groups, before the start of the study and after completion of treatment,have to do ultrasound of the liver,evaluation of serum levels of liver enzymes, AST and ALT and ALP, and the results in between the two groups will be compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201705261165N20
Registration date: 2017-07-23, 1396/05/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
baqiatallah hospital
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
therapeutic Effect and safety of squill oxymel in control of fatty liver disease in patients with mild to moderate fatty liver
Public title
Effect of squill oxymel in control of mild to moderate fatty liver
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: To Sign the consent form Knowingly patients be suffered from mild to moderate fatty liver According to the ultrasound result. Exclusion criteria: Off treatment for more than a week Progression of Fatty liver disease Person is pregnant or lactating Allergic reactions to herbal blend
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
simple randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the Islamic Azad University of Pharmaceutical Science
Street address
Islamic Azad University of Pharmaceutical Science; Yasaman alley; Yakhchal street; Doctor shariatie; Tehran; Iran
City
tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ir.iau.ps.rec.1394.35

Health conditions studied

1

Description of health condition studied
fatty liver
ICD-10 code
k76.0
ICD-10 code description
k75.8

Primary outcomes

1

Description
improvment of quality of life
Timepoint
at baseline and 2 month after intervention
Method of measurement
quality of life questionnaire

2

Description
FBS
Timepoint
at baseline and 2 month after intervention
Method of measurement
mg/dl

3

Description
triglycerides
Timepoint
at baseline and 2 month after intervention
Method of measurement
mg/dl

4

Description
cholesterol
Timepoint
at baseline and 2 month after intervention
Method of measurement
mg/dl

5

Description
hdl
Timepoint
at baseline and 2 month after intervention
Method of measurement
mg/dl

6

Description
ldl
Timepoint
at baseline and 2 month after intervention
Method of measurement
mg/dl

7

Description
alt
Timepoint
at baseline and 2 month after intervention
Method of measurement
iu/l

8

Description
ast
Timepoint
at baseline and 2 month after intervention
Method of measurement
iu/l

9

Description
alp
Timepoint
at baseline and 2 month after intervention
Method of measurement
iu/l

10

Description
grade of fatty liver
Timepoint
at baseline and 2 month after intervention
Method of measurement
sonography

Secondary outcomes

1

Description
bmi
Timepoint
at baseline and 2 month after intervention
Method of measurement
kg/m2

Intervention groups

1

Description
intervention:squill oxymel,scientific name:drimia maritima. each 5 ml contains 25 mg of squill. dose of consumption:30 ml daily (orally).devided 3 times a day. duration of consumption:2 month. gorgan-niak-co
Category
Treatment - Drugs

2

Description
control:placebo oxymel,15 cc daily,until 2 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
digestion clinic,baqiatallah hospital
Full name of responsible person
Dr yuns panahi
Street address
Nosrati Ave., South sheykhbahaee St., Mollasadra St.
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Baqiyatallah University of medical sciences
Full name of responsible person
dr yunes panahi
Street address
Nosrati Ave., South sheykhbahaee St., Mollasadra St.
City
tehran
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 Baqiyatallah University of medical 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
pharmaceutical sciences branch islamic azad university
Full name of responsible person
fateme hadei
Position
doctorate of pharmacy
Other areas of specialty/work
Street address
Islamic Azad University of Pharmaceutical Science; Yasaman alley; Yakhchal street; Doctor shariatie; Tehran; Ira
City
tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
chemical injuries reaserch center,baqiatallah university of medical sciences
Full name of responsible person
dr yunes panahi
Position
clinical pharmacist
Other areas of specialty/work
Street address
Nosrati Ave., South sheykhbahaee St., Mollasadra St.
City
tehran
Postal code
Phone
+98 21 8248 2516
Fax
Email
yunepanahi@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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