Medicinal plants with regarding benefit effects traditionally had special role in health of society. So, this study was done to evaluate the effect of Berberis integerrima extract on hypertriglyceridemia and fatty liver disease improvement.
Design
Clinical trial with pre- post control.
Settings and conduct
Mofatteh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Inclusion criteria of patients are tree times of blood experiment for triglyceride and sonography response for patients with fatty liver. Total patients with hypertriglyceridemia including males and females with 20-70 age range is essential for inclusion to study.
exclusion criteria:
Out of ranges 20-70 years.
Sectional increase of triglyceride.
Individuals which had not compliance for administration in duration of study for regularly Berberis integerrima extract.
Intervention groups
Barberry plant is considered as one of the vegetation cover of mountainous regions of Iran. In all parts of this plant, there are alkaloid berberin, oxyacantine and briamine. Due to the beneficial effects of black barberry on a variety of physical disorders, the traditional medicine recommends the use of black barberry in liver problems. So, in this study, the effect of barberry extract on triglyceride decrease and its action for the treatment of fatty liver will evaluate.
Main outcome variables
Fatty liver, triglyceride
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190220042772N1
Registration date:2019-03-15, 1397/12/24
Registration timing:registered_while_recruiting
Last update:2019-03-15, 1397/12/24
Update count:0
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
Mousalreza Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 1622
Email address
r.mohamadi@iauvaramin.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-10-06, 1397/07/14
Actual recruitment start date
2019-03-03, 1397/12/12
Actual recruitment end date
2019-11-05, 1398/08/14
Trial completion date
2020-01-05, 1398/10/15
Scientific title
Effect of aqueous Berberis integerrima extract on fatty liver and triglyceridemia in patients with fatty liver and hypertriglyceridemia
Public title
Berberis integerrima effect on fatty liver and triglyceride
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria of patients are tree times of blood experiment for triglyceride and sonography response for patients with fatty liver.
Total patients with hypertriglyceridemia including males and females.
20-70 age range is essential for inclusion to study.
Exclusion criteria:
Out of ranges 20-70 years.
Sectional increase of triglyceride
Individuals which had not compliance for administration of permanently Berberis integerrima extract. ( Duration of study)
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Actual sample size reached:
188
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Varamin- Pishva Branch
Street address
University street, Naghsh Jahan Town,
City
Varamin, Pishva
Province
Tehran
Postal code
3381774895
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR. IAU. Varamin. REC.1395,3
Health conditions studied
1
Description of health condition studied
Hypertriglyceridemia
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridaemia, Endogenous hyperglyceridaemia
2
Description of health condition studied
Fatty liver
ICD-10 code
k76.0
ICD-10 code description
Nonalcoholic fatty liver disease
Primary outcomes
1
Description
patients with hypertriglyceridemia
Timepoint
Measurement of triglyceride value before consumption of Berberis integerrima extract and two months after daily consumption of Berberis integerrima extract.
Method of measurement
triglyceride kit
2
Description
Patients with non- alcoholic fatty liver disease
Timepoint
Evaluation of fatty liver before consumption of Berberis integerrima extract and two months after daily consumption of its.