The Clinical Trial on the Eradication of Helicobacter Pylori With Bismuth Agent Quadruple and Modified Ban Xia Xie Xin Decoction
Sponsor study identifier
interventional
600
0 countries
N/A
Study Start
November 1, 2022
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Primary Completion
September 30, 2024
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Study Completion
September 30, 2024
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2022
Actual (reported)October 19, 2022
Actual (reported)November 1, 2022
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September 30, 2024
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September 30, 2024
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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
Side effects of bismuth quadruple
45days
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).
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).
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).
First Submitted
October 5, 2022
First Posted
October 19, 2022
Study Start
November 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2024
Estimated (date passed)Effectiveness of Once-daily Dose Regimen of 7-day and 14-day High Dose Rabeprazole-levofloxacin Based Quadruple Therapy for H. Pylori Eradication in Thai Patients With Non-ulcer Dyspepsia
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).
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Study Completion
September 30, 2024
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Last Updated
October 19, 2022
Record last verified: 2022-09
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