A multicentric study of interferon - ribavirin combination therapy and interferon - glycyrrizin combination therapy in the management of chronic hepatitis C

ICMR0 个研究点目标入组 125 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•AL T > 60 IU / L
•Histological activity index (HAl) > 3
•Willing to be treated on an out-patient basis for 24 weeks
•Willing to give blood specimens initially, on days 2, 4 & 8 and subsequently at 4-weekly intervals during 24-wk treatment period and once in 12 weeks during the 24-wk follow-up period
•Willing to undergo liver biopsies thrice i.e., initially, at week 24 (optional) and after completion of F. U (week 48)
•Etiology of HCV

•Fibrosis score> 5 (as per Knodell's scoring system)
•Serum bilirubin >3.0 mg%
•Prothrombin time 6 seconds prolonged than control
•Coronary artery, respiratory or any other disease with expected survival less than one year
•Major depressive illness, cytopenias, hyperthyroidism, renal transplantation, and evidence of auto-immune disease, Wilson's disease or co-infection with HIV
•Multiple transfusions like thalassemics and haemophiliacs
•Use of intravenous or oral narcotic drugs
•Receiving immuno-suppressive therapy for other associated illnesses
•Interferon therapy during the past 6 months
•Use of known hepatotoxic drugs, oral contraceptives, herbal medicines or cortico-steroids during the past 3 months
•Alcoholism [2 drinks (80 gm) per day for more than one year]
•Lactating mother with infant aged less than 6 months

发起方

ICMR