drugset / Trial / NCT05586464

Eradication of Helicobacter Pylori With Bismuth Agent Quadruple and Traditional Chinese Medicine

NCT05586464

Phase 1 Unknown 600 enrolled Liaocheng People's Hospital
RandomizedFactorialOpen-labelTreatment

Summary

This study is a prospective randomized case-control study. Six hundred patients who were firstly diagnosed as Helicobacter pylori infection will be selected, and then randomly assigned into case group and control group. Patients in control group take bismuth quadruplicate for 14 days. Patients in case group take Ban xia xie xin Decoction and bismuth agent quadruple for 14 days. Exhalation test or stool Helicobacter pylori antigen detection were used to assess the eradication rate of Helicobacter pylori 30 days (the 45th day) after treatment; Adverse reactions were evaluated on the first day (15th day) and the 30th day (45th day) after treatment. The eradication rate of Helicobacter pylori and the adverse drug reactions during the medication will be evaluated. The effect of Ban xia xie xin Decoction and bismuth quadruple based on furazolidone on the eradication of helicobacter pylori infection will be explored.

Timeline

Start
2022-11-01
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Banxiaxiexin decoction Unknown
Comparator Amoxicillin Other / unclassified 100 mg
Comparator Esomeprazole Small molecule 20 mg
Comparator Furazolidone Small molecule 100 mg
Background pectin bismuth gel Unknown 150 mg
Comparator pectin bismuth gel Unknown 150 mg