Evaluation of the effect of Ciochorium intibus syrup on clinical and para clinical manifestations of patients with non-alcoholic fatty liver
Design
This clinical trial is conducted on 100 patients in two groups of 50, including a control group and parallel groups. This study is single-blind and simple randomization is used
Settings and conduct
This study is carried out on patients with active fatty liver of grade 2 and higher (high liver enzymes and ultrasound evidence) referring to Qaem and Imam Reza hospitals in Mashhad.These patients have no involvement in active chronic hepatitis, active viral hepatitis, metabolic liver diseases, autoimmune diseases, drug side effects and do not consume alcohol, and are randomly assigned to two groups receiving drug treatment for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria : age of over 20 and below 60; higher than 40 alanine aminotransferase and aspartate aminotransferase serum levels; fatty liver with grade 2 and higher; body mass index of over 27
Exclusion criteria : pregnancy and breastfeeding; use of alcohol; previous history of confirmed liver diseases; use of any diet or drug for the treatment of fatty liver within the last 3 months; autoimmune diseases and all types of malignancy
Intervention groups
Intervention group: Patients are treated with Ciochorium intibus syrup for two months, receiving 8 cc of the syrup three times a day, half an hour before each meal. Metformin is also given as the common drug.
Control group: The control group receives placebo syrup. Metformin is also given as the common drug.
Main outcome variables
Changes in fatty liver grade; serum levels of alanine aminotransferase and aspartate aminotransferase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041431N1
Registration date:2019-03-09, 1397/12/18
Registration timing:prospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Hossein Ramezani hodk
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3225 4307
Email address
ramezanihh2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ciochorium intibus syrup on clinical and para clinical manifestations of patients with non-alcoholic fatty liver
Public title
Effectiveness of Ciochorium intibus syrup on non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of over 20 and below 60
Higher than 40 alanine aminotransferase and aspartate aminotransferase serum levels
Fatty liver with grade 2 and higher
Body mass index of over 27
Exclusion criteria:
Pregnancy and breastfeeding
Use of alcohol
Previous history of confirmed liver diseases
Use of any diet or drug for the treatment of fatty liver within the last 3 months
Confirmed autoimmune diseases
All types of malignancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be based on a random allocation table provided by a computer. In order to conceal the random allocation of the groups, sealed envelopes will be used. Then, the envelopes are opened in sequence for each patient and the method of treatment becomes known.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single-blind study in which the participants are unaware of their treatments, and the type of drug treatment is based on sealed envelopes.
Placebo
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
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.704
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Serum level of alanine aminotransferase
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
Biochemical tests
2
Description
Serum level of aspartate aminotransferase
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
Biochemical tests
3
Description
Change in fatty liver grade
Timepoint
Before and after intervention
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are treated with Ciochorium intibus syrup for two months, receiving 8 cc of the syrup three times a day, half an hour before each meal. Metformin is also given as the common drug.
Category
Treatment - Drugs
2
Description
Control group: The control group receives placebo syrup. Metformin is also given as the common drug.