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The Effect of Berberis Vulgaris Fruits Extract on Alanine Aminotransfrase ,Aspartate Aminotransfrase,Serum Lipid and Fasting Blood Glucose of Non-Alcoholic Steatohepatitis in Patients Referred to Clinic Martyr Motahhari Shiraz in 1390

Protocol summary

Summary
The aim of this clinical trial is to study the effect of Berberis Vulgaris on non alcoholic steatohepatitis in patients with nonalcoholic fatty liver disease. in Design of This Study 80 patients will be included That major including criteria are : older than 20 years with nonalcoholic-fatty liver disease and liver enzymes> 42 and proportion of ALT/ AST> 1. The fatty liver will be recognized by sonography. Exclusion criteria are : using drugs that affect liver tests during the last 2 , viral hepatitis, hemochromatosis, autoimmune hepatitis, cirrhosis,Type 1 diabetes , Alcohol dependency, Pregnancy,Breast feeding, and Infectious diseases.in Intervention : Intervention group will be administrated 750 mg of Berberis Vulgaris Fruits Extract BID during 3 month and control group will be given placebo. main outcomes are : Liver enzymes and fasting blood sugar That will be assessed Before, after 45 days and 3 months of treatment course, tri glycirid, total cholestrol, LDL and HDL Will be Measured Before and End of Study. be

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202068505N2
Registration date: 2012-09-20, 1391/06/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-20, 1391/06/30
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology of Shiraz university of medical sciences
Expected recruitment start date
2011-07-28, 1390/05/06
Expected recruitment end date
2012-01-26, 1390/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Berberis Vulgaris Fruits Extract on Alanine Aminotransfrase ,Aspartate Aminotransfrase,Serum Lipid and Fasting Blood Glucose of Non-Alcoholic Steatohepatitis in Patients Referred to Clinic Martyr Motahhari Shiraz in 1390
Public title
Effect of Barberry on Non Alcoholic
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria : older than 20 years with nonalcoholic- fatty liver disease; liver enzymes>42 and proportion of ALT/ AST>1. Excluding criteria : using drugs that affect liver tests during the last 2 months; viral hepatitis; hemochromatosis; autoimmune hepatitis; cirrhosis;type 1 diabetes; alcohol dependency; pregnancy; breast feeding and infectious diseases
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: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Shiraz University of Medical Scineces
Street address
Seventh Floor of Shiraz University of Medical Sciences and Health Services, Next to red crescent organazation, Zand blvd
City
Shiraz
Postal code
Approval date
2012-04-03, 1391/01/15
Ethics committee reference number
CT-91-6081

Health conditions studied

1

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

Primary outcomes

1

Description
ALT
Timepoint
Before, 45 days and 3 month after the therapy
Method of measurement
Laboratory

2

Description
AST
Timepoint
Before, 45 days and 3 month after the therapy
Method of measurement
Laboratory

3

Description
FBS
Timepoint
Before, 45 days and 3 month after the therapy
Method of measurement
Laboratory

Secondary outcomes

1

Description
Chol-T
Timepoint
Before and 3 months after the therapy
Method of measurement
laboratory

2

Description
Triglycirid
Timepoint
Before and 3 months after the therapy
Method of measurement
laboratory

3

Description
LDL
Timepoint
Before and 3 months after the therapy
Method of measurement
laboratory

4

Description
HDL
Timepoint
Before and 3 months after the therapy
Method of measurement
laboratory

Intervention groups

1

Description
Intervention group : 750 mg of Berberis Vulgaris Fruits Extract, BID during 3 months
Category
Treatment - Drugs

2

Description
Control group : placebo, with same shape, color and packaging without active drug.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahary Polyclinic
Full name of responsible person
Dr; Ali Jangju
Street address
Zand Street, Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Seventh Floor of Shiraz university of Medical Sciences and Health Services, Next to Red Crescent Organazation, Zand blvd
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Raziye Iloun Kashkooli
Position
MSc.Student of Nursing
Other areas of specialty/work
Street address
No 7179617474, Sarv Street, Baharan Town, Shiraz
City
Shiraz
Postal code
7179617474
Phone
+98 71 1840 3755
Fax
Email
raziiloon@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Seyed Kazem Hosseini Asl
Position
Associate Professor of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Namazi Hospital, Zand Street, Namazi Square, Shiraz
City
Shiraz
Postal code
11351-71937
Phone
+98 71 1212 5610
Fax
Email
hoseiniasl@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Raziye Iloun Kashkooli
Position
Other areas of specialty/work
Street address
No 7179617474, Sarv Street, Baharan Town, Shiraz
City
Shiraz
Postal code
7179617474
Phone
+98 71 1840 3755
Fax
Email
raziiloon@yahoo.com
Web page address

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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