NCT04786795

MITE in the Treatment of Dyspepsia After Cholecystectomy

MITE (Compound Azintamide Enteric-coated Tablets) in the Treatment of Dyspepsia After Cholecystectomy: a Multicenter, Randomized, Superior, Parallel Controlled Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 990 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control drug, to observe its safety, and to evaluate the quality of life of subjects before and after treatment

Detailed description

This study is a multi-center, randomized, superiority and parallel controlled clinical study. Third-party institutions will generate random codes according to random numbers of the software and divide them into two groups (Compound Azintamide Enteric-coated Tablets Group, Oryz-aspergillus Enzyme and Pancreatin Tablet and Ursodeoxycholic Acid Tablets Group) in a ratio of 1:1. Random numbers will be sealed and stored in radiopaque envelopes, which will be managed by a designated person not involved in the specific study. Specific intervention measures: If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets, and the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit

Conditions

• Patients With Dyspeptic Symptoms After Cholecystectomy

Interventions

Type	Name	Description
DRUG	Compound Azintamide Enteric-coated Tablets	the experimental group takes Compound Azintamide Enteric-coated Tablets.They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
DRUG	Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets	the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2021-03-08
• Last updated: 2021-03-08