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The efficacy and safety of Weifuchun tablets versus bismuth potassium citrate in combination with standard triple therapy for the first-line treatment of Helicobacter pylori infection: A randomized controlled trial

The efficacy and safety of Weifuchun tablets versus bismuth potassium citrate in combination with standard triple therapy for the first-line treatment of Helicobacter pylori infection: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008279
Enrollment
Unknown
Registered
2016-04-13
Start date
2016-04-25
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Helicobacter pylori Infection

Interventions

Weifuchun quadruple regimen:Weifuchun tablets, esomeprazole, amoxicillin and clarithromycin
Bismuth quadruple regimen:Bismuth potassium citrate, esomeprazole, amoxicillin and clarithromycin
Standard triple regimen:Esomeprazole, amoxicillin and clarithromycin

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiao Tong university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease confirmed by upper endoscopy; 2. H. pylori infection confirmed by RUT, 13C-UBT,culture; 3. Never received treatment for H. pylori infection; 4. Voluntarily participated in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Less than 18 years old; 2. Previous H. pylori eradication therapy; 3. With previous gastric surgery; 4. Severe concomitant cardiovascular, respiratory, renal, hepatic, hematological, neurological, endocrine or psychiatric diseases; 5. Pregnancy or lactation; 6. Allergy to any of the study drugs; 7. Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Design outcomes

Primary

MeasureTime frame
Eradication rate of H. pylori;

Secondary

MeasureTime frame
Adverse event rate;Compliance rate;

Countries

China

Contacts

Public ContactHong Lu

Renji Hospital, School of Medicine, Shanghai Jiao Tong university

hlu@sjtu.edu.cn+86 13611958022

Outcome results

None listed

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