A comparative evaluation of combination therapy of Lamivudine and Colchicine comparing with Lamivudine and placebo in clinical and laboratory improvement of chronic hepatitis B
The purpose of this study is to assess the efficacy of combination therapy of Lamivudine and Colchicine comparing with Lamivudine alone for treatment of chronic viral hepatitis B. In this double blind study, 100 patients with serologic and biochemical confirmed chronic hepatits B will be randomize into treatment group (Lamivudine l00mg daily and Colchicine 0.5 mg daily, for 6 months) or control group (Lamivudine l00mg daily and placebo once daily, for 6 months). Patients should be HBS Ag positive serologically and their alanine aminotransferase levels (ALT) be at least two fold of normal range will be enrolled in the study. Alcoholic patients, HCV antibody positive patients, patients with HIV infection, metabolic liver disease, right cardiac heart failure, or hypersensitivity to drugs will be excluded. At the end of therapy, serum ALT, serum bilirubin, serum Albumin and PT will be evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807112539N1
Registration date:2009-11-08, 1388/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-11-08, 1388/08/17
Registrant information
Name
Amir Hassanpour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1367 4405
Email address
drhassanpor@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2009-07-06, 1388/04/15
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of combination therapy of Lamivudine and Colchicine comparing with Lamivudine and placebo in clinical and laboratory improvement of chronic hepatitis B
Public title
Assessment of Colchicine efficacy in treatment of chronic hepatitis B
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: positive HBS Ag, confirmed chronic hepatitis B, ALT level at least twofold of normal range
Exclusion criteria: positive HCV Ab, positive HIV Ab, Alcohol abuse, Presence of auto immune hepatitis, metabolic liver disease, right cardiac failure or pulmonary hypertension, low compliance, allergic reaction to drugs or sever side effect of drugs, presence of decompensate cirrhosis (PT>20 sec and ALb<3 gr/dl)