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

NCT ID: NCT05364619

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QHD group

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

Group Type EXPERIMENTAL

Qingre Huashi Granules combined the modified dual therapy

Intervention Type DRUG

Qingre Huashi Granules combined the modified dual therapy for 14 days

Control group

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

Group Type ACTIVE_COMPARATOR

Bismuth containing quadruple therapy

Intervention Type DRUG

Bismuth containing quadruple therapy for 14 days

Interventions

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Qingre Huashi Granules combined the modified dual therapy

Qingre Huashi Granules combined the modified dual therapy for 14 days

Intervention Type DRUG

Bismuth containing quadruple therapy

Bismuth containing quadruple therapy for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University International Hospital

OTHER

Sponsor Role collaborator

Beijing Geriatric Hospital

OTHER

Sponsor Role collaborator

Beijing Changping Integrative Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Changping Integrative Medicine Hospital

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Peking University International Hospital

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Countries

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China

Central Contacts

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HUI YE, Doctor

Role: CONTACT

+86010 83572351

Facility Contacts

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HUI YE

Role: primary

+86 10 83572351

Other Identifiers

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ShouFa-2022-2-40711

Identifier Type: -

Identifier Source: org_study_id

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