Given the increasing prevalence of cirrhosis and high burden of mortality and morbidity due to this condition, finding new effective agents to prevent the progression of the disease or slowing the rate of liver destruction and fibrosis. N-acetyl cysteine (NAC) have been approved for treatment of hepatic injury caused by acetaminophen toxicity. Recent animal studies have indicated the anti-inflammatory, anti-oxidant and anti-fibrotic effects of this drug. Thus in this study, we investigate the effects of NAC on hepatic function of cirrhotic patients.
Design
A randomized placebo-controlled double-blind clinical trial
Settings and conduct
All patients referred to the gastroenterology clinic in Taleghani Hospital with definitive diagnosis of liver cirrhosis that met inclusion criteria will be randomly divided into intervention and control groups. Demographic data and baseline tests, Child and MELD Score will be checked and calculated. All tests and Child-pugh and MELD Scores will be checked at the end of the 6 month period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-70 year-old patients with established diagnosis of cirrhosis with known etiology. Exclusion criteria: Patients with episodes of gastrointestinal bleeding and/or severe infections resulting in hospital admission at any time during the study period will be excluded.
Intervention groups
Intervention group: patients will receive 600 mg tablets of NAC twice a day.
En Control group: Patients will receive placebo tablets completely similar to NAC tablets once.
Main outcome variables
Liver function evaluation by Child-Puff score system with scores categorized as A, B and C ; Liver function evaluation by MELD scoring system based on bilirubin and creatinine serum levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043734N1
Registration date:2019-09-06, 1398/06/15
Registration timing:prospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Maryam Masoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 1839
Email address
maryammasoumii666@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of N-acetyl cysteine in cirrhotic patients
Public title
Studying the effect of N-acetyl cysteine in cirrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Child suffering class A or B of cirrhosis
Patients with score of 5-9 of child pugh score
Exclusion criteria:
Patient with class c of child pugh score
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization, individually, will be performed using a sealed envelope by placing the patient numbers of 1 to 80 in two groups or the same in two envelopes. Only the researcher knows which group the envelopes and numbers belong to and allocation concealment will be double blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be aware of the effective intervention on health but without awareness of its type. The physician and researcher and data collector will be kept blind to the type of the intervention. The data analyzer is also kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences