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Efficacy and safety of tigorazan triple therapy versus bismuth-containing quadruple therapy in the first-line treatment of Helicobacter pylori infection: a prospective, randomized, controlled study

Efficacy and safety of tigorazan triple therapy versus bismuth-containing quadruple therapy in the first-line treatment of Helicobacter pylori infection: a prospective, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102215
Enrollment
Unknown
Registered
2025-05-12
Start date
2023-08-09
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Helicobacter pylori infection

Interventions

Group A: 14-day Tigorazan triple therapy:Tigorazan 50mg twice a day Amoxicillin 1000mg twice a day Doxycycline 100mg twice a day
Group B: 14-day tigorazan bismuth-containing quadruple therapy:Tigorazan 50mg twice a day Amoxicillin 1000mg twice a day Doxycycline 100mg twice a day Bismuth potassium citrate 600mg twice a day

Sponsors

Wenzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70 years old, male or female. (2) Helicobacter pylori infection (13C/14C urea breath test positive) (3) Patients who had not previously received Helicobacter pylori eradication therapy

Exclusion criteria

Exclusion criteria: (1) Serious underlying diseases, such as liver insufficiency (AST or ALT greater than 3 times the normal value), renal insufficiency (Cr>=2.0mg/dL or GFR = 75%) (2) Those who are not willing to take contraceptive measures during pregnancy, lactation and the test (3) Active bleeding of digestive tract (4) Test drug allergy history (5) Use history of bismuth, antibiotics, PPI and other drugs within 4 weeks (6) other behaviors that may increase the risk of the disease, such as alcohol and drug use (7) Unable or unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Safety, compliance, and adverse reactions;

Countries

China

Contacts

Public ContactPan Jie/Zhou Qingjie

Wenzhou Central Hospital

783202415@qq.com+86 137 0665 8031

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 7, 2026