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Health impact of Melatonin, Metformin and Ursodeoxycholic acid in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD)

Protocol summary

Summary
Objectives: The objective of this study is comparison of therapeutic effect of Melatonin, Metformin and Ursodeoxycholic acid with placebo in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD). Design: Patients with NAFLD who have proven steatosis by Fibroscan, during the double-blind randomized clinical trials are under treatment regimen. Setting and conduct: Patients divided into three groups and one control group. This pilot study would be with a sample size of 120. For the patients at the beginning and end of the project weight, height, waist circumference, BMI, Cholesterol, TG, LDL, HDL, FBS, HbA1C, INR, PTT, PT, Billirubin (Total, Direct), Albumin, AST, ALT, ALK-P, CRP, the steatosis and hepatic fibrosis patients is measured. Exclusion criteria: Consumption more than 20 gram of alcohol per day for women or more than 30 gram in men for at least 3 consecutive months during five last years; people with hepatitis B,C; chronic liver disease; heart failure; consumer of osteoarthritis medications that cause hepatitis; proven diabetes mellitus; proven hemochromatosis and unwillingness to participate in the project. Intervention: This study will be a pilot study with 120 sample size. Patients enter one of four categories for three months: Intervention group 1: The group that received tabs Melatonin, 10 milligram, one number, daily (Manufacturing factory is Nachermed of America); Intervention group 2: Tab Metformin, 500 milligram, one number, every 12 hours (Manufacturing factory is Aria); Intervention Group 3: Cap Ursodeoxycholic acid, 300 milligram, one number, every 12 hours (Manufacturing factory is Sosefarm of Italia); Control group: Tab Placebo, one number, daily. Diet respected in all groups. At the end of the study, the frequency of existence statuses and fibrosis in patients each group based on the results of Fibro scan and also check liver enzyme levels and other tests will be calculated. Main outcome measures: primary outcome variables are the Body Mass Index and Serum levels of liver enzymes. Also, the secondary outcome variables are serum lipids and Body Mass Index respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407201155N21
Registration date: 2015-09-22, 1394/06/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-22, 1394/06/31
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and Liver Disease Research Center
Expected recruitment start date
2015-06-09, 1394/03/19
Expected recruitment end date
2016-03-09, 1394/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Health impact of Melatonin, Metformin and Ursodeoxycholic acid in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD)
Public title
Comparison of therapeutic effect of Melatonin, Metformin and Ursodeoxycholic acid with placebo in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Nonalcoholic Fatty Liver Disease (NAFLD) have proven statuses by Fibro Scan. Exclusion criteria: Consumption more than 20 gram of alcohol per day for women or more than 30 gram in men for at least 3 consecutive months during five last years; patients with hepatitis B, C and other chronic liver diseases including autoimmune liver diseases; patients with heart failure according to the history and clinical signs; patients who take medication causing osteohepatitis such as Tamoxifen, Amiodarone; patients with established diabetes mellitus; patients with established hemochromatosis; dissatisfaction for participate in study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The randomization in this study is Random Block

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gastrointestinal and Liver Disease Research Center of Guilan University of Medic
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht
Postal code
4144895655
Approval date
2014-07-09, 1393/04/18
Ethics committee reference number
ش-182

Health conditions studied

1

Description of health condition studied
Nonalcoholic Fatty Liver Disease (NAFLD)
ICD-10 code
K 76.0
ICD-10 code description
Nonalcoholic Fatty Liver Disease (NAFLD)

Primary outcomes

1

Description
Serum levels of liver enzymes
Timepoint
initially and three months later
Method of measurement
Laboratory Kit

2

Description
Steatosis
Timepoint
initially and three months later
Method of measurement
using fibroscan

Secondary outcomes

1

Description
Serum Lipids
Timepoint
Initially and three months later
Method of measurement
Laboratory Kit

2

Description
Body Mass Index
Timepoint
Initially and three months later
Method of measurement
with Seca Scale

Intervention groups

1

Description
Intervention group 1:Melatonin,10 milligram, one number, daily
Category
Treatment - Drugs

2

Description
Intervention group 2: Tab Metformin, 500 milligram one number, every 12 hours
Category
Treatment - Drugs

3

Description
Intervention group 3: Cap Ursodeoxycholic acid, 300 milligram, one number, daily
Category
Treatment - Drugs

4

Description
Control group: Tab Placebo, one number, daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr Rasool Tabari KHomeirani
Street address
Sadati Street, Namjoo Street, Rasht ,Guilan,Iran
City
Rasht
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 Guilan University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Behvazan Company
Full name of responsible person
Dr. seyed Mohamad Keshavarz
Street address
Rasht industrialcirty Behvazan Company
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behvazan Company
Proportion provided by this source
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
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Farahnaz Joukar
Position
Assistant of Gastrointestinal and Liver Disease Research Center
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht
Postal code
Phone
+98 13133535116
Fax
Email
F_Jokar@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Position
Professor of internal medicine and gastroenterology and hepatology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Mehrnaz Asgharnezhad
Position
Researcher of Gastrointestinal and Liver Disease Research Center
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue, Rasht, Guilan province, Iran
City
Rasht
Postal code
4144895655
Phone
00
Fax
Email
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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