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Randomized controlled clinical trial of Helicobacter pylori eradication with a drug-sensitive high-dose clarithromycin dual regimen

Randomized controlled clinical trial of Helicobacter pylori eradication with a drug-sensitive high-dose clarithromycin dual regimen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099396
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Helicobacter pylori infection

Interventions

Experimental group:Venorosine: 20mg bid + Clarithromycin: 750mg bid for 14 days
control group:Venolazine: 20mg bid + Clarithromycin: 750mg bid for 10 days

Sponsors

Nansha Hospital, Guangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Agreed to enroll patients; 2. Age 18-60 years old; 3. Hp infection was confirmed and Hp drug sensitive culture was performed through gastroscopy, indicating clarithromycin sensitive patients.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, patients with recent childbearing plans 2. Persons with disabilities defined by law (blind, deaf, dumb, intellectual disability, mental disorder, physical disability); 3. Patients with previous allergy to experimental drugs (clarithromycin, vonoprazan); 4. Continuous use of adrenocortical steroids, nonsteroidal anti-inflammatory drugs, and anticoagulants; 5. Previous history of gastric surgery; 6. Use of PPI and P-CAB drugs in the past 2 weeks, use of antibiotics, bismuth and traditional Chinese medicine with antibacterial effect in the past 4 weeks; 7. Suspected or true history of alcohol and drug abuse. 8. Severe organic diseases of the digestive system, such as malignant tumors of the digestive tract, gastrointestinal bleeding, peptic ulcer with perforation/obstruction, intestinal obstruction, etc. 9. Severe systemic diseases, such as severe cardiovascular and cerebrovascular diseases, diabetes mellitus, chronic renal insufficiency, connective tissue diseases, nervous system diseases, etc. 10. There were other factors considered by the investigator to be unsuitable for inclusion or to preclude participation in the study

Design outcomes

Primary

MeasureTime frame
14C breath test, 14C-UBT;The eradication rate of Hp in the two groups;

Secondary

MeasureTime frame
Incidence of adverse drug reactions;

Countries

China

Contacts

Public ContactJia Li

Nansha Hospital, Guangzhou First People's Hospital

2806393963@qq.com+86 150 1302 1841

Outcome results

None listed

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