Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection

Peking University

Status: Enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Qingre Huashi Granules combined the modified dual therapy; Drug: Bismuth containing quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05364619

ShouFa-2022-2-40711

Details and patient eligibility

About

This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.

Enrollment: 160 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current Helicobacter pylori infection.
• Age ≥ 60 years.
• Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
• Signed the informed consent document.

Exclusion criteria

• History of Helicobacter pylori treatment.
• History of gastric surgery.
• Allergic to any medications involved in the intervention.
• Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR<60ml/min'1.73m2) , malignant tumor，mental disorder.
• Taking medications that may be conflict to the intervention drugs.
• Failing to express symptoms, unwilling to cooperate.
• Taking any antibiotics within a month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

QHD group

Experimental group

Description:

Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days.

Treatment:

Drug: Qingre Huashi Granules combined the modified dual therapy

Control group

Active Comparator group

Description:

Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days.

Treatment:

Drug: Bismuth containing quadruple therapy