Purpose: This study a randomized clinical trial that aims to evaluate and compare the conventional medicine diet, and a diet based on Iranian traditional medicine for the treatment of patients with non-alcoholic fatty liver(NAFLD): RCT Study population: 100 patients have been randomized (Simple block randomization) were selected and divided four groups The first group NAFLD with body mass index(BMI) Less than or equal 27 will be treated with conventional medicine diet, this treatment consists of feeding a diet low in calories and fat . Group II (NAFLD with BMI greater than 27 and less than or equal 30 ) will be treated with Venostat capsules (500 milligram 2 times a day) and also conventional medicine diet. The third group (NAFLD with BMI less than or equal 27 ) treated with diet based on Iranian traditional medicine. Group IV (NAFLD with BMI greater than 27 and less than or equal 30 ) will be treated with diet based on Iranian traditional medicine and also Hepatomelis (herbal tea consisting of Meslisa officinalis and Nigella sativa) twice daily .Groups I and II (conventional medicine) are considered as the control group, third and fourth groups (Iranian traditional medicine) are considered as intervention group. Patients will be controlled once every two weeks by the physician responsible design. Intervention time 3 months. Primary outcome or consequences of the study: laboratory changes ALT, AST, and Ultrasound Image of liver and changes in body mass index(BMI)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081518807N1
Registration date:2015-01-12, 1393/10/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-12, 1393/10/22
Registrant information
Name
Gholam reza Ghayour razmgah
Name of organization / entity
Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
ghayourgh1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-10-06, 1393/07/14
Expected recruitment end date
2015-04-22, 1394/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian traditional medicine-based diet on Non-alcoholic fatty liver(NAFLD)
Public title
Effect of Iranian traditional medicine-based diet on Non-alcoholic fatty liver(NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 60 years؛ the detection of Non-alcoholic fatty liver(NAFLD)by Ultrasound Images (grade 1 or 2 or 3 ). Exclusion criteria: diabetes; heart disease; hypertension; over weight(BMI greater than 30 ). familial hyperlipidemia; active alcohol or addiction; discourage patients from continuing to participate in the plan; Breastfeeding; Pregnancy; Any other chronic diseases such as kidney stones, gallstones, cardiovascular surgery; abdominal surgery; CVA; acute hepatitis; acute Pancreatitis; major Surgery during the last 6 months and also any surgery on the liver and gallbladder. Rapid weight loss during the last 3 months for any reason. Drop Out Criteria: Any medication side effects during treatment; Other acute illnesses during the study period who had liver adverse impact on yield: Such as gallstones and surgery and general anesthesia and drugs with liver toxicity;
Increase in liver enzymes (AST, ALT) and Fasting blood sugar (FBS) during the study period; Consent to continue participating in the study; Alcohol and alcoholic beverages during the study period; Drug use is incorrect; Failure to follow the prescribed diet; Not see the patient during follow up; pregnancy and breastfeeding women participating in the project.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Danehgah Street,Vice chancellor for research, University of Medical Sciences, Mashhad
City
Mashhad
Postal code
Approval date
2014-09-09, 1393/06/18
Ethics committee reference number
research.922501.1.1109
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver(NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Measure levels of liver enzymes (AST , ALT)
Timepoint
Before the intervention; 6 weeks after the intervention;End of the intervention (3 months)
Method of measurement
Autoanalyzer
Secondary outcomes
1
Description
Ultrasound Images of liver;Fatty tissue infiltration in liver (grade 1 or 2 or 3 )
Timepoint
Before the intervention;6 weeks after the intervention ;End of the intervention (3 months)
Method of measurement
The grading of fatty liver infiltration of fat tissue based on ultrasound by one radiologist
2
Description
Body mass index (BMI)
Timepoint
Before the intervention;6 weeks after the intervention ;End of the intervention (3 months)
Method of measurement
Weight and height measurements by one person in the same center.
Intervention groups
1
Description
Control group: the detection of Non-alcoholic fatty¬ liver ( NAFLD) by Ultrasound Images (grade 1 or 2 or 3 ) with body mass index(BMI) Less than or equal 27 will be treated with conventional medicine diet, (this treatment consists of feeding a diet low in calories and fat), and (NAFLD) with BMI greater than 27 and less than or equal 30 will be treated with Venostat capsules (500 milligram 2 times a day) and also conventional medicine diet for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group: NAFLD Patients has Body Mass Index (BMI less than 27) treated with diet based on Iranian traditional medicine and NAFLD patient has body mass index (BMI) greater than 27 and less than or equal 30 will be treated with diet based on Iranian traditional medicine and also Hepatomelis (herbal tea consisting of Melissa officinalis and Nigella sativa) twice daily for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Gastrointestinal Clinic
Full name of responsible person
Seyyd Musa Al-Reza Hosseini
Street address
Ahmadabad Street ,Ghaem Hospital,Ghaem Gastrointestinal Clinic,Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Faculty of Traditional Medicine Clinic
Full name of responsible person
Gholam reza Ghayour razmgah
Street address
Bahar st - Jahad st - front of Mehran stadium
City
Mashhad
3
Recruitment center
Name of recruitment center
Nutrition clinic of Ghaem Hospital
Full name of responsible person
Mohsen Nematy
Street address
Quaem.Medical.Cente
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Said Islame
Street address
Ghoreish Building, Daneshgah Street, University of Medical Sciences, Vice chancellor for research, Mashhad
City
Mashhad
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 Mashhad 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
Faculty of Traditional Medicine
Full name of responsible person
Gholam reza Ghayour razmgah
Position
Phd student Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51338536780
Email
ghayourgh1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medicine Internal Clinic, Ghaem Hospital
Full name of responsible person
Seyyd Musa Al-Reza Hosseini
Position
Subspecialist of Gastroenterology
Other areas of specialty/work
Street address
Ahmadabad Street, Department of Medicine Internal, Ghaem Hospital,
City
Mashhad
Postal code
9176699199
Phone
+98 51138400001
Fax
+98 38012742
Email
HoseiniMR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
Gholam reza Ghayour razmgah
Position
Phd student Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine of Mashhad
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51338535980
Email
ghayourgh1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)