Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized,Placebo-controlled,Double-blind Trial of Phyllanthus Urinaria (Hepaguard®) in Adults With Nonalcoholic Steatohepatitis|
- Histologic NAFLD activity score [ Time Frame: week 24 ]
- ALT normalization [ Time Frame: week 24 & week 48 ]
- Metabolic endpoints [ Time Frame: Weeks 12, 24, 36 and 48 ]
- Changes in magnetic resonance spectroscopy [ Time Frame: Weeks 24 and 48 ]
- Liver stiffness measurement [ Time Frame: Weeks 24 and 48 ]
- Biomarkers of NASH and liver fibrosis [ Time Frame: Weeks 12, 24, 36 and 48 ]
|Study Start Date:||May 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Hepaguard||
Drug: Phyllanthus urinaria
Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance. At week 24, subjects receiving active Hepaguard will be randomized (1:1) to continue Hepaguard for another 24 weeks or stop treatment.
Other Name: Hepaguard®
|Placebo Comparator: Placebo||
Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01210989
|Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital|
|Hong Kong SAR, China|