Cirrhosis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study to Evaluate the Safety and Efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Improving Malnutrition in Patients With Cirrhosis
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 2 groups, including Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group). Treatment group includes 99 subjects, while control group includes 33 subjects. They receive investigational drug 2 tablets/times, tid, p.o. for 180 days.
- A total of 132 subjects with cirrhosis were divided into 3 subgroups by Child-Pugh
score, which were Child-pugh Class A, B, and C, respectively. Each subgroup includes 44
subjects, which were randomly assigned to the Oryz-Aspergillus Enzyme and Pancreatin
tablet group (treatment group) and the placebo group (control group) in a ratio of 3: 1
(33: 11).
- Patients who have signed the Informed Consent Form and are eligible for the entry
criteria will be randomly assigned to either the Oryz-Aspergillus Enzyme and Pancreatin
tablet group or the placebo group. No matter which group the subjects is assigned,
he/she would receive treatment drugs through oral administration for 180 days, during
which the participant will not take any investigational drug.
- The differences in nutritional status between treatment group and control group will be
compared in 90 and 180 days by MAMC and SGA.
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