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

October 17, 2022 updated by: Liaocheng People's Hospital

The Clinical Trial on the Eradication of Helicobacter Pylori With Bismuth Agent Quadruple and Modified Ban Xia Xie Xin Decoction

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori is a primary carcinogen of gastric cancer. Helicobacter pylori infection rate is about 50% in China. Helicobacter pylori infection should be eradicated unless there are countervailing factors. The bismuth agent quadruple (PPI+bismuth pectin+2 kinds of antibiotics) has eradicated the first line therapy of H. Pylori infection. The rise of antibiotic resistance rate leads to the decline of eradication rate of H. pylori. Traditional Chinese medicine played an important role in the treatment of H. pylori infection. This study explored the application of Ban xia xie xin Decoction and bismuth agent quadruple based on furazolidone in the role of the eradication of H. Pylori infection. 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. The case group was named as Traditional Chinese Medicine group. Patients in the case group will take Ban xia xie xin Decoction and bismuth quadruplicate for 14 days. The control group was named as bismuth quadruplicate group. Patients in the control group will take bismuth quadruplicate for 14 days. Bismuth quadruplicate includes esomeprazole (nexium 20mg bid), amoxicillin (amoxicillin 1.0 bid), furazolidone (100mg bid) and pectin bismuth gel (150mg qid). Ban xia xie xin Decoction includes 10g of banxia, 10g of huangqin, 6g of coptis chinensis, 6g of dried ginger, 6g of ginseng, 6g of roasted licorice, 6g of Chinese jujube. One dose in the morning and one dose in the evening, and take after meals. 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 on the eradication of helicobacter pylori infection will be explored.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. H. Pylori infection: Carbon13/Carbon14-urea breath test positive or rapid urease test positive or gastric mucosal tissue pathological section positive immunohistochemistry staining or gastric mucosal tissue positive H. pylori culture or fecal Positive detection of H. pylori antigen.
  2. No history of H. Pylori infection eradication therapy;
  3. Age 18-70 years
  4. H.Pylori infection check was completed within 1 month before the start of the study.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. There are other serious diseases that affect the evaluation of this study, such as severe coronary heart disease, liver disease, kidney disease, chronic obstructive pulmonary disease, malignant tumor, and psychosocial diseases;
  3. History of major or complex gastrointestinal surgery;
  4. Those who are allergic to the drugs used in this study;
  5. Patients participate other drug studies within 3 months;
  6. Patients can not cooperate with the experimenter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traditional Chinese Medicine group

Patients in the case group will take Ban xia xie xin Decoction and bismuth quadruplicate for 14 days. H. pylori was rechecked one month after drug withdrawal, and H. pylori clearance rate and adverse reactions were observed in the reorganized patients.

Ban xia xie xin Decoction includes 10g of banxia, 10g of huangqin, 6g of coptis chinensis, 6g of dried ginger, 6g of ginseng, 6g of roasted licorice, 6g of Chinese jujube. One dose in the morning and one dose in the evening, and take after meals.

Bismuth quadruplicate includes esomeprazole (nexium, Tablets 20mg/tablet, 20mg bid), amoxicillin ( Tablets 25mg/tablet,100mg bid), furazolidone (Tablets100mg/tablet,100mg bid) and pectin bismuth gel (Gel 150mg/bag, 150mg qid).
Drug: Ban xia xie xin Decoction and bismuth quadruplicate group
Ban xia xie xin Decoction:10g of banxia, 10g of huangqin, 6g of coptis chinensis, 6g of dried ginger, 6g of ginseng, 6g of roasted licorice, 6g of Chinese jujube Bismuth quadruplicate: Esomeprazole (nexium, Tablets 20mg/tablet, 20mg bid), amoxicillin ( Tablets 25mg/tablet,100mg bid), furazolidone (Tablets100mg/tablet,100mg bid) and pectin bismuth gel (Gel 150mg/bag, 150mg qid).
Other Names:
  • Ban xia xie xin Decoction
  • Bismuth quadruplicate
Active Comparator: Bismuth quadruplicate group

Patients in the control group will take bismuth quadruplicate for 14 days. H. pylori was rechecked one month after drug withdrawal, and H. pylori clearance rate and adverse reactions were observed in the reorganized patients.

Bismuth quadruplicate includes esomeprazole (nexium, Tablets 20mg/tablet, 20mg bid), amoxicillin ( Tablets 25mg/tablet,100mg bid), furazolidone (Tablets100mg/tablet,100mg bid) and pectin bismuth gel (Gel 150mg/bag, 150mg qid).
Drug: Bismuth quadruplicate group
Bismuth quadruplicate: Esomeprazole (nexium, Tablets 20mg/tablet, 20mg bid), amoxicillin ( Tablets 25mg/tablet,100mg bid), furazolidone (Tablets100mg/tablet,100mg bid) and pectin bismuth gel (Gel 150mg/bag, 150mg qid).
Other Names:
  • Bismuth quadruplicate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The helicobacter pylori clearance rate in case group and control group.
Time Frame: 45days
The participants in the case group and the control group were tested for H. pylori after one month of drug withdrawal. If H. pylori was negative, the clearance was successful. The clearance rate of H. pylori was calculated (number of HP negative patients/number of patients included in this group).
45days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of bismuth quadruple
Time Frame: 45days
The participants observe whether there are drug-related adverse reactions during and within 30 days after taking the bismuth quadruple. The main side effects of bismuth quadruplex include diarrhea, constipation, abdominal pain, dizziness, headache, rash, insomnia, arthralgia, taste change (oral odor), and others.
45days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaocheng People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456 (Innovate UK)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helicobacter Pylori Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe