MITE in the Treatment of Dyspepsia After Cholecystectomy
NCT04786795 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 990
Last updated 2021-03-08
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
Conditions
- Patients With Dyspeptic Symptoms After Cholecystectomy
Interventions
- 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
Sponsors & Collaborators
-
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-01
- Primary Completion
- 2022-02-01
- Completion
- 2022-02-28
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