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Single center, randomized, controlled, open, non inferiority clinical trial of the quadruple therapy of Qingwei Zhitong pellets instead of bismuth in the treatment of helicobacter pylori

Single center, randomized, controlled, open, non inferiority clinical trial of the quadruple therapy of Qingwei Zhitong pellets instead of bismuth in the treatment of helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066296
Enrollment
Unknown
Registered
2022-11-30
Start date
2022-10-31
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

Helicobacter pylori

Interventions

Experimental group:10mg Bid for breakfast and 0.5-1h before dinner, 3.2 g Tid for rabeprazole, 0.5-1h before lunch and 0.5-1h before dinner, 1g Bid for Amoxicillin, take Clarithromycin 500mg Bid at br
Control group: Rabeprazole 10 mg Bid at breakfast and 0.5-1 h before dinner, bismuth complex 2.6 g tid at breakfast, lunch and 0.5-1 h before dinner, Amoxicillin 1g Bid, take Clarithromycin 500mg Bid

Sponsors

Civil Aviation General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) For those aged 18-75 (including the boundary values at both ends), gender is not limited; 2) The result of 13C or 14C urea breath test is H Those with positive pylori infection; 3) People with symptoms of upper digestive tract, such as epigastric pain, acid regurgitation, heartburn, epigastric distension, nausea, one or more. 4) Before screening, subjects have fully understood the study and voluntarily signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) The first half year of screening has passed the standard H Pylori eradication therapists; 2) Those who have used proton pump inhibitors or H2 receptor antagonists, antibiotics, bismuth agents, and gastric mucosal protective agents within 4 weeks before screening; 3) Those who have used macrolides and penicillins repeatedly (5 times or more within one year) or for a long time (10 weeks or more); 4) Those who are allergic to any component of the test related drugs (bismuth, rabeprazole, antibiotics [penicillin (amoxicillin, etc.), macrolides (clarithromycin, etc.), and Qingwei Zhitong pellets]) or have contraindications to the test related drugs; 5) Patients with malignant tumor or history of esophageal and gastrointestinal surgery; 6) Patients with pyloric obstruction, gastric perforation and Zoe Ai syndrome; 7) Patients with acute upper gastrointestinal bleeding within 1 week before screening; 8) Those who need to take drugs that affect anticoagulation system, coagulation system, fibrinolysis system or non steroidal anti-inflammatory drugs during the test; 9) Other serious heart, liver and kidney dysfunction (ALT, AST>1.5 times the upper limit of normal value or Cr>the upper limit of normal value), anemia (Hb<90g/L) and other serious hematopoiesis and coagulation system diseases can not be effectively controlled; 10) Pregnant or lactating women, or subjects with positive pregnancy test, or with birth plan within 6 months after screening test; 11) Those who have a history of drug or alcohol abuse within one year before screening, or do not agree to abide by the provisions of the test (including prohibition of drinking) during the study period; 12) The researcher comprehensively judged that it was not suitable to participate in the clinical trial

Design outcomes

Primary

MeasureTime frame
13C urea breath test;

Countries

China

Contacts

Public ContactJianping Cheng

Civil Aviation General Hospital

cjpczy2004@163.com15811282039

Outcome results

None listed

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