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

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Qingre Huashi Granules combined the modified dual therapy; Drug: Bismuth containing quadruple therapy

• Registration Number: NCT05364619
• Lead Sponsor: Peking University First Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2022-08-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QHD group	Qingre Huashi Granules combined the modified dual therapy	Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days.
Control group	Bismuth containing quadruple therapy	Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	The 4th week after the treatment.	At the 4th week after the treatment, the 13-carbon urease test was conducted to evaluate the eradication condition. The value of "delta over baseline" \<4 was considered to be successful eradication.

Secondary Outcome Measures

Name	Time	Method
7-point Global Overall Symptom Scale	Baseline, the second and sixth week after the treatment, respectively.	The 7-point Global Overall Symptom Scale was used to record and evaluate the symptoms. The scale value ranges from 7 to 56. The higher scale means the worse outcome.
Efficacy Scale of the Dampness-heat syndrome	Baseline, the second and sixth week after the treatment, respectively.	The Scale of the Dampness-heat syndrome was used to record and evaluate the symptoms related to the Traditional Chinese Medicine symptoms. The scale value ranges from 0 to 24. The higher scale means the worse outcome.
Adverse events rate	During the follow-up, up to 6 weeks.	Any adverse event related to the drugs will be recorded during the entire follow-up period.

Trial Locations

Locations (3)

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Changping Integrative Medicine Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China