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

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Qingre Huashi Granules combined the modified dual therapy
Bismuth containing quadruple therapy
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First HospitalRecruiting
  • Beijing Changping Integrative Medicine Hospital
  • Peking University International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QHD group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2022
Last Updated
October 17, 2022
Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Beijing Geriatric Hospital, Beijing Changping Integrative Medicine Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05364619
Brief Title
Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection
Official Title
Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Beijing Geriatric Hospital, Beijing Changping Integrative Medicine Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QHD group
Arm Type
Experimental
Arm Description
Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days.
Intervention Type
Drug
Intervention Name(s)
Qingre Huashi Granules combined the modified dual therapy
Intervention Description
Qingre Huashi Granules combined the modified dual therapy for 14 days
Intervention Type
Drug
Intervention Name(s)
Bismuth containing quadruple therapy
Intervention Description
Bismuth containing quadruple therapy for 14 days
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
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 Outcome Measure Information:
Title
7-point Global Overall Symptom Scale
Description
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.
Title
Efficacy Scale of the Dampness-heat syndrome
Description
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.
Title
Adverse events rate
Description
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.
Other Pre-specified Outcome Measures:
Title
CYP2C19 Genotype
Description
Failed cases will receive the CYP2C19 Genotype test.
Time Frame
The sixth week after the treatment.
Title
Helicobacter pylori antibody test.
Description
The antibody of anti-UREA, anti-UREB, anti-CagA, and anti-VacA was tested.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HUI YE, Doctor
Phone
+86010 83572351
Email
brightleaf723@163.com
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HUI YE
Phone
+86 10 83572351
Email
brightleaf723@163.com
Facility Name
Beijing Changping Integrative Medicine Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University International Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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