Helicobacter pylori infection
Conditions
Interventions
Experimental group:Omeprazole enteric-coated capsules 20 mg twice daily (bid), taken 0.5–1 hour before breakfast and dinner
Zuojin Capsules 4 capsules twice daily (bid), taken 0.5–1 hour before breakfast and dinner
Amoxicillin capsules 1 g twice daily (bid), taken before breakfast and dinner
Clarithromycin tablets 500 mg twice daily (bid), taken before breakfast and dinner.
Control group:Omeprazole enteric-coated capsules 20 mg twice daily (bid), taken 0.5–1 hour before breakfast and dinner
Bismuth potassium citrate capsules 240 mg twice daily (bid), taken 0.5–1 hour before breakfast and dinner
Sponsors
The first Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years (inclusive), regardless of gender. 2. Positive for Helicobacter pylori infection confirmed by 13C urea breath test (13C-UBT = 6‰). 3. Meeting the TCM syndrome criteria of **stagnant heat in the liver and stomach** or **damp-heat in the spleen and stomach**, and having at least one upper gastrointestinal symptom such as epigastric pain, acid reflux, heartburn, upper abdominal distension, or nausea. 4. Treatment-naive patients who are receiving initial H. pylori eradication therapy. 5. No contraindications or known adverse reactions to the study drugs; able to understand the study procedures and methods, and willing to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received standard H. pylori eradication therapy before screening. 2. Patients diagnosed with cold syndrome according to traditional Chinese medicine (TCM) syndrome differentiation. 3. Patients who have used proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, bismuth preparations, or gastric mucosal protectants within 4 weeks before screening. 4. Patients with a history of repeated use (=5 times within 1 year) or long-term use (=10 consecutive weeks) of macrolides or penicillins. 5. Patients with a known allergy to any component of the study-related drugs (bismuth, omeprazole, antibiotics [penicillins such as amoxicillin, macrolides such as clarithromycin], or Zuojin Capsule), or with contraindications to any of the study-related drugs; patients with a history of penicillin allergy. 6. Patients with concurrent malignant tumors or a history of esophageal, gastric, or intestinal surgery. 7. Patients with contraindications to gastroscopy, including acute upper gastrointestinal bleeding, active gastric or duodenal ulcers, acute gastric or duodenal mucosal injury, chronic atrophic gastritis with moderate-to-severe dysplasia, or gastritis in a gastric remnant. 8. Patients with concurrent pyloric obstruction, gastric perforation, or Zollinger-Ellison syndrome. 9. Patients who need to take drugs affecting the anticoagulant, coagulation, or fibrinolytic systems during the trial period. 10. Patients with concurrent severe cardiac, hepatic, or renal insufficiency (ALT or AST >1.5× upper limit of normal [ULN], or Cr > ULN), anemia (Hb < 90 g/L), or other serious uncontrolled hematopoietic or coagulation disorders. 11. Pregnant or lactating women, women with a positive pregnancy test, or subjects planning to conceive within 6 months after screening. 12. Patients who are unable to use effective contraception during the trial period. 13. Patients with a history of drug or alcohol abuse within 1 year before screening, or those who refuse to comply with trial requirements (including alcohol prohibition) during the study period. 14. Patients requiring long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs). 15. Patients who have used weight-control medications (including weight-loss drugs) within 3 months. 16. Patients with severe diseases that may be life-threatening during the treatment or follow-up period. 17. Patients with mental or neurological disorders that prevent them from expressing informed consent or cooperating with examinations and treatment. 18. Patients with alcoholism or a history of drug abuse/addiction. 19. Patients who have participated in other clinical trials of drugs or medical devices within 3 months. 20. Patients with other concurrent conditions that, in the investigator's judgment, would prevent evaluation of efficacy or completion of the intended treatment course and follow-up. 21. Patients who, in the investigator's overall judgment, are unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate;Evaluate the incidence of grayish-black stools in the two quadruple therapy groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in TCM syndrome scores;Post-treatment gastrointestinal symptom remission rate; | — |
Countries
China
Contacts
Public ContactYuan Zhengzhong
The first Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed