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

Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Qingre Huashi Granules combined the modified dual therapy; Drug: Bismuth containing quadruple therapy

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUI YE, Doctor; Phone Number: +86010 83572351; Email: brightleaf723@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: HUI YE; Phone Number: +86 10 83572351; Email: brightleaf723@163.com
    • Beijing, Beijing, China
      • Active, not recruiting
      • Beijing Changping Integrative Medicine Hospital
    • Beijing, Beijing, China
      • Active, not recruiting
      • Peking University International Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QHD group; Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days.	Drug: Qingre Huashi Granules combined the modified dual therapy; Qingre Huashi Granules combined the modified dual therapy for 14 days
Active Comparator: 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.	Drug: Bismuth containing quadruple therapy; Bismuth containing quadruple therapy for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The 4th week after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	During the follow-up, up to 6 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CYP2C19 Genotype	Failed cases will receive the CYP2C19 Genotype test.	The sixth week after the treatment.
Helicobacter pylori antibody test.	The antibody of anti-UREA, anti-UREB, anti-CagA, and anti-VacA was tested.	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Dual therapy; Bismuth-containing quadruple therapy; Geriatic; Qingre Huashi Decoction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: ShouFa-2022-2-40711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No