Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction
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.
Interventions
DRUGQingre Huashi Granules combined the modified dual therapy
Qingre Huashi Granules combined the modified dual therapy for 14 days
DRUGBismuth containing quadruple therapy
Bismuth containing quadruple therapy for 14 days
Sponsors
Peking University International Hospital
Beijing Geriatric Hospital
Beijing Changping Integrative Medicine Hospital
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | The 4th week after the treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| 7-point Global Overall Symptom Scale | Baseline, the second and sixth week after the treatment, respectively. | 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 | Baseline, the second and sixth week after the treatment, respectively. | 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 | During the follow-up, up to 6 weeks. | Any adverse event related to the drugs will be recorded during the entire follow-up period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| CYP2C19 Genotype | The sixth week after the treatment. | Failed cases will receive the CYP2C19 Genotype test. |
| Helicobacter pylori antibody test. | Baseline | The antibody of anti-UREA, anti-UREB, anti-CagA, and anti-VacA was tested. |
Countries
China
Contacts
Primary ContactHUI YE, Doctor
Outcome results
None listed