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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Beijing Changping Integrative Medicine Hospital; Beijing Geriatric Hospital; Peking University International Hospital
• Treatments: Bismuth

Criteria

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.