Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide.
Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a
progressive course and may result in liver cirrhosis and liver cancer. However, there is yet
proven treatment for this disorder. In cell line and animal studies, we have shown that
Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation.
Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the
efficacy in NASH has not been confirmed in humans.
This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH
will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy.
Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of
Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue
Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be
further analyzed.