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Single-center, prospective, randomized, controlled, open clinical study of clear gastric analgesic micropill combined with standard tetraplex therapy for H. pylori

Single-center, prospective, randomized, controlled, open clinical study of clear gastric analgesic micropill combined with standard tetraplex therapy for H. pylori

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077090
Enrollment
Unknown
Registered
2023-10-30
Start date
2023-10-30
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

helicobacter pylori infection

Interventions

Test group:Test group: pentatherapy of gastric analgesic micro pill, gastric analgesic micro pill for 28 days, 14 days (rebeprazole 20mg Bid, 0.5-1h before breakfast and dinner
compound bismuth aluminate 2.6 gtid, 0.5-1h after breakfast, lunch and dinner
gastric analgesic micropill 3.2 gTid, once before breakfast, lunch and 0.5-1h before dinner
amoxicillin 1g Bid, once after breakfast and dinner
clarithromycin 500mg Bid, once after breakfast and dinner)
Control group A:Control group A: quadruple therapy containing bismuth for 14 days (rabeprazole 20mg Bid, once 0.5-1h before breakfast and dinner
compound bismuth aluminate 2.6 gtid, once after breakfast, lunch and 0.5-1h after dinner
amoxicillin 1g Bid, once immediately after breakfast and dinner
clarithromycin 500mg Bid, once immediately after breakfast and dinner)
Control group B:Control group B: quadruple therapy for 14 days (mg Bid 20, taken once after breakfast and 0.5-1h before dinner
3.2 g Tid, taken once after breakfast, lunch and 0.5-1h after dinner
amoxicillin 1g Bid, taken once after breakfast and dinner
clarithromycin 500mg Bid, taken once after breakfast and dinner)

Sponsors

Civil Aviation General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18-75 years old (including the value at both ends); 2) Those who are positive by 13C or 14C urea breath test for H. pylori infection; 3) Patients with upper gastrointestinal symptoms, such as: upper abdominal pain, acid reflux, heartburn, upper abdominal distension, nausea, one or more patients. 4) Participants were fully informed of the study and voluntarily signed written informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who have undergone regular H. pylori eradication treatment within half a year before screening; 2) Those who have used proton pump inhibitors or H2 receptor antagonists, antibiotics, bismuth and gastric mucosal protecagents within 4 weeks before screening; 3) Previous repeated use (5 times or more times within a year) or long-term (continuous use for 10 weeks or more) use of macrolide, penicillin drugs; 4) Allergic to any component of test-related drugs (bismuth, rabeprazole, antibiotics [penicillin (amoxicillin, etc.), macrolides (clarithromycin, etc.), gastric analgesic micro pill]) or have test-related drug contraindications; 5) Patients with malignant tumors or a history of esophageal and gastrointestinal surgery; 6) Patients with pyloric obstruction, gastricperforation and Zhuo-AIDS syndrome; 7) Patients with acute upper gastrointestinal bleeding within 1 week before screening; 8) Take the drugs or non-steroidal anti-inflammatory drugs affecting the anticoagulant system, coagulation system and fibrinolytic system during the test; 9) Combined with other serious cardiac, liver and renal insufficiency (ALT, AST> 1.5 times upper limit of normal value or Cr> upper limit of normal value), anemia (Hb <90g / L) and other serious hematopoietic and coagulation diseases failed to be effectively controlled; 10) Pregnant or lactating women, or subjects with a positive pregnancy test, or who have a birth plan within 6 months of the screening test; 11) Have a history of drug or alcohol abuse within 1 year prior to screening, or do not agree to comply with the provisions of the trial (including alcohol prohibition) during the study; 12) The investigator is not suitable to participate in clinical studies

Design outcomes

Primary

MeasureTime frame
C13;Eradication rate of H. pylori;

Secondary

MeasureTime frame
Gastrointestinal Symptoms Rating Scales;Adverse Effects Rate;

Countries

China

Contacts

Public ContactJianping Cheng

Civil Aviation General Hospital

cjpczy2004@163.com+86 158 1128 2039

Outcome results

None listed

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