Skip to content

A randomized controlled clinical study of Jianpiqushijiedutongluo decoction combined with salvage quadruple therapy on Drug-Resistant Helicobacter Pylori Infection

Science and Technology Innovation Project of China Academy of Chinese Medical Sciences - Major Research Project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066868
Enrollment
Unknown
Registered
2022-12-20
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Resistant Helicobacter Pylori Infection

Interventions

treatment group A:Jianpiqushijiedutongluo decoction combined with salvage quadruple therapy
control group:salvage quadruple therapy

Sponsors

Guang’anmen Hospital,China Academynof Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?Meet the diagnostic criteria of traditional Chinese medicine and western medicine for H.pylori infection;?Patients meet conditions that they have failed =2 times of treatment with standard eradication regimen in the past 2 years,levofloxacin and/or clarithromycin have been included in the treatment regimen, and the withdrawal time was at least 3 months from eradication therapy;?Helicobacter pylori detection meets one of the following conditions: 2 weeks before the treatment, the result of 13C/14C-urea breath test,urease test in gastric mucosal biopsy under gastroscope or positive staining of tissue sections is positive;?Age from 18 to 70 years; ?Patients with good compliance, voluntary and able to cooperate with the treatment, and sign the informed consent.

Exclusion criteria

Exclusion criteria: ?Taking antibiotics, bismuth, proton pump inhibitors, H2 receptor blockers, non-steroidal anti-inflammatory drugs and heat-clearing and detoxifying herbs before treatment; ?Pregnant or lactating women; ?Combined with serious underlying diseases, such as malignant tumors; ? The result of endoscopic examination is active ulcers, patients had previous history of upper gastrointestinal surgery;?Liver and kidney function tests were performed and the results were abnormal and clinically significant;?Mental and legal disability patients; ?Patients were suspected or determined the history of alcohol and drug abuse, or with other lesions that may reduce the possibility of participation or complicate the group;?Patients who are allergic to the drugs of study.

Design outcomes

Primary

MeasureTime frame
The eradication rate of H.pylori;

Secondary

MeasureTime frame
Traditional Chinese Medicine symptom score;HADS score;EQ-5D;

Countries

China

Contacts

Public ContactLiu Zhen

Guang’anmen Hospital,China Academy of Chinese Medical Sciences/ Xi yuan Hospital,China Academy of Chinese Medical Sciences

doctorliuzhen@126.com13581553766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026