The aim of this study is evaluation of the effect of curcumin supplement on disease activity in patients with liver cirrhosis.
Design
70 person after taking informed consent consist of 35 patient with liver cirrhosis in case group and 35 patient with the liver cirrhosis in control group conducted parallel double blinded in the trial.
Settings and conduct
The trial will be performed in Tabriz Emam Reza hospital in the special liver cirrhosis clinic by managing study and control groups. Curcumin supplement(500mg) and placebo will be administerated twice a day for 90days, while patients and physician are blind in the study. Lab tests will be obtained and documented when referring patients to the clinic on schedules and at the end, by using the computer software the data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-65
MELD score < 18
PaO2 u> 60mmHg
Without hepatocellular carcinoma and hepatopulmonary syndrome and pulmonary hypertension and without consumption of anti platelet and anti coagulant
without Choleliyhiasis and Bladder stone
Exclusion criteria:Exceeding of MELD score > 18
PaO2 <60 mmHg
Hepatopulmonary syndrome
Pulmonary artery pressure > 25 mmHg
Hyper oxaluria
Hillar chlangio carcinoma
Cystic fibrosis with FEV1< 40%
Intervention groups
In case group 1000mg of Curcumin supplement divided in 2 doses daily for the months will be described and the control group will take placebo
Main outcome variables
MELD(i) Score, MELD Score, Child-Paugh Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180802040678N1
Registration date:2018-12-31, 1397/10/10
Registration timing:registered_while_recruiting
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Masoud Nouri-Vaskeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3325 9778
Email address
mnvaskeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-19, 1397/09/28
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin supplement on disease activity in patients with liver cirrhosis
Public title
Effect of Curcumin supplement on disease activity in patients with liver cirrhosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
MELD Score below 18
PaO2 upper than 60 mmHg
without Hepato Cellular Carcinoma
Without Hepato pulmonary syndrome
Without consumption of antiplatelet and anti coagulant drugs
Without Cholelithiasis and Bladder stone
Exclusion criteria:
MELD Score above 18
PaO2 less than 60 mmHg
Hepato pulmonary syndrome
Pulmonary artery pressure above 25mmHg
Hyper Oxaluria
Hillar cholangio carcinoma
Cystic fibrosis with FEV1 less than 40%
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomizing by computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
participants-healthcare provider-data collectors
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Ave.