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

NCT05586464 | Unknown Phase 1

• 1 other identifier: 123456
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Helicobacter Pylori Infection; Traditional Chinese Medicine; Eradication

Keywords

Helicobacter Pylori Infection; Traditional Chinese Medicine; Furazolidone; Amoxicillin; Esomeprazole; Pectin bismuth gel

Outcome Measures

Primary Outcomes (1)

• The helicobacter pylori clearance rate in case group and control group.

  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 Outcomes (1)

• Side effects of bismuth quadruple

  45days

Study Arms (2)

Traditional Chinese Medicine group

EXPERIMENTAL

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

Bismuth quadruplicate group

ACTIVE COMPARATOR

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

Interventions

Ban xia xie xin Decoction and bismuth quadruplicate group DRUG

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).

Also known as: Ban xia xie xin Decoction, Bismuth quadruplicate

Traditional Chinese Medicine group

Bismuth quadruplicate group DRUG

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).

Also known as: Bismuth quadruplicate

Bismuth quadruplicate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No history of H. Pylori infection eradication therapy;
• Age 18-70 years
• H.Pylori infection check was completed within 1 month before the start of the study.

You may not qualify if:

• Pregnant or lactating women;
• 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;
• History of major or complex gastrointestinal surgery;
• Those who are allergic to the drugs used in this study;
• Patients participate other drug studies within 3 months;
• Patients can not cooperate with the experimenter.

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 19, 2022
• Study Start: November 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-09