Effect of dandelion capsule on improvement of liver fibrosis and liver function test among patients with non-alcoholic fatty liver disease
Design
Randomized controlled trial, with two arm parallel group of 50 patients, will be enrolled between December 2018 and December 2019, and will follow for 3 months.
Settings and conduct
In this research, 50 eligible patients whit non-alcoholic fatty liver disease referring to Qom gastroenterology clinic were chosen. Then, patients by block randomization were randomly divided into two control and intervention groups. The intervention group will receive dandelion capsule and control group will receive placebo capsule. Participants does not know the intervention type
Participants/Inclusion and exclusion criteria
Inclusion criteria: grade 2 and 3 of Non-alcoholic fatty liver, hemoglobin above 13 in male and above 12 in female. Exclusion criteria: history of allergy to plants of asteraceae, diabetes and renal failure, pregnant and lactating women
Intervention groups
Intervention group: dandelion capsule, 300 mg, oral, twice a day, for 3 months. Control group: placebo capsule, oral, twice a day, for 3 months.
Main outcome variables
Liver stiffness change; change of liver enzymes levels in serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N10
Registration date:2018-11-22, 1397/09/01
Registration timing:registered_while_recruiting
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dandelion capsule on improvement of liver fibrosis and liver function test among patients with non-alcoholic fatty liver disease
Public title
Effect of dandelion capsule on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 2 and 3 of Non-alcoholic fatty liver
Hemoglobin above 13 in male and above 12 in female
Exclusion criteria:
History of allergy to plants of asteraceae
Bile duct or intestinal obstruction
Diabetes and renal failure
Pregnant and lactating women
Weight below 50 kg
Consumers of lithium, tetracyclines, fluoroquinolones, blood glucose lowering drugs and blood thinners drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be assigned to two groups of intervention and control by block randomization. For this purpose blocks of size 4 will be used. Six blocks will include BAAB, ABBA, BABA, BBAA, ABAB, AABB. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessor does not know the allocation
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.MUQ.REC.1397.128
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
2
Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver stiffness
Timepoint
Three months after treatment
Method of measurement
Fibroscan
Secondary outcomes
1
Description
Blood levels of liver enzymes
Timepoint
Three months after treatment
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Dandelion capsule, 300 mg, oral, twice a day, for 3 months
Category
Treatment - Drugs
2
Description
Control group: placebo capsule, oral, twice a day, for 3 months