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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364619
• Other study ID #: ShouFa-2022-2-40711
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Peking University First Hospital
• Contact: HUI YE, Doctor
• Phone: +86010 83572351
• Email: brightleaf723[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Qingre Huashi Granules combined the modified dual therapy
Qingre Huashi Granules combined the modified dual therapy for 14 days
• Bismuth containing quadruple therapy
Bismuth containing quadruple therapy for 14 days

Locations

Country	Name	City	State
China	Beijing Changping Integrative Medicine Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Changping Integrative Medicine Hospital, Beijing Geriatric Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CYP2C19 Genotype	Failed cases will receive the CYP2C19 Genotype test.	The sixth week after the treatment.
Other	Helicobacter pylori antibody test.	The antibody of anti-UREA, anti-UREB, anti-CagA, and anti-VacA was tested.	Baseline
Primary	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	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.
Secondary	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.
Secondary	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.