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

Peking University First Hospital160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Helicobacter Pylori Infection

Interventions

Qingre Huashi Granules combined the modified dual therapyDRUG

Qingre Huashi Granules combined the modified dual therapy for 14 days

Bismuth containing quadruple therapyDRUG

Bismuth containing quadruple therapy for 14 days

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (3)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Changping Integrative Medicine Hospital

Beijing, Beijing Municipality, China

ACTIVE_NOT_RECRUITING

Peking University International Hospital

Beijing, Beijing Municipality, China

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

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.

Time frame: The 4th week after the treatment.

Secondary Outcomes

7-point Global Overall Symptom Scale

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.

Time frame: Baseline, the second and sixth week after the treatment, respectively.

Efficacy Scale of the Dampness-heat syndrome

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.

Time frame: Baseline, the second and sixth week after the treatment, respectively.

Adverse events rate

Any adverse event related to the drugs will be recorded during the entire follow-up period.

Time frame: During the follow-up, up to 6 weeks.

Central Contacts

HUI YE, Doctor

CONTACT

+86010 83572351 brightleaf723@163.com

Data from ClinicalTrials.gov

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