NCT04057326

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	Oryz-Aspergillus Enzyme and Pancreatin Tablet	2 tablets/time, 3 times daily,Oral Administration.
DRUG	Placebo	2 tablets/time, 3 times daily,Oral Administration.

Timeline

• Start date: 2019-08-30
• Primary completion: 2020-12-30
• Completion: 2021-03-28
• First posted: 2019-08-15
• Last updated: 2019-08-15