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A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition

2019-08-20 20:17:13 | BioPortfolio

Summary

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.

Description

- 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.

Study Design

Conditions

Cirrhosis

Intervention

Oryz-Aspergillus Enzyme and Pancreatin Tablet, Placebo

Status

Not yet recruiting

Source

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-20T20:17:13-0400

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