NCT05364619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

April 24, 2022

Last Update Submit

October 17, 2022

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriGeriaticDual therapyBismuth-containing quadruple therapyQingre Huashi Decoction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 7-point Global Overall Symptom Scale

    Baseline, the second and sixth week after the treatment, respectively.

  • Efficacy Scale of the Dampness-heat syndrome

    Baseline, the second and sixth week after the treatment, respectively.

  • Adverse events rate

    During the follow-up, up to 6 weeks.

Other Outcomes (2)

  • CYP2C19 Genotype

    The sixth week after the treatment.

  • Helicobacter pylori antibody test.

    Baseline

Study Arms (2)

QHD group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Qingre Huashi Granules combined the modified dual therapyDRUG

Qingre Huashi Granules combined the modified dual therapy for 14 days

QHD group
Bismuth containing quadruple therapyDRUG

Bismuth containing quadruple therapy for 14 days

Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current Helicobacter pylori infection.
  • Age ≥ 60 years.
  • Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
  • Signed the informed consent document.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, 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

Central Study Contacts

HUI YE, Doctor

CONTACT

+86010 83572351brightleaf723@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2022

First Posted

May 6, 2022

Study Start

August 5, 2022

Primary Completion

December 1, 2024

Study Completion

December 31, 2024

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

CN(3)