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A multicenter, randomized, open and parallel controlled clinical study of Ganhai Weikang capsule combined with standard triple therapy in the treatment of Helicobacter pylori positive gastritis in China.

A multicenter, randomized, open and parallel controlled clinical study of Ganhai Weikang capsule combined with standard triple therapy in the treatment of Helicobacter pylori positive gastritis in China.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000362
Enrollment
Unknown
Registered
2024-09-03
Start date
2022-11-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Helicobacter pylori positive gastritis

Interventions

Control group:Rabeprazole sodium enteric-coated capsules+amoxicillin capsules+tetracycline tablets+bismuth potassium citrate capsules.
Test group A1:Rabeprazole sodium enteric-coated capsules+amoxicillin capsules+tetracycline tablets+Ganhai Weikang capsules, with a course of 14 days.
Test group A2:Rabeprazole sodium enteric-coated capsules+amoxicillin capsules+tetracycline tablets+Ganhai Weikang capsules the course of treatment was 14 days and Ganhai Weikang continued to be a sing

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~65 years old, regardless of sex; 2. Hp-positive patients with chronic gastritis (1) HP-positive refers to the positive urea breath test within one month before joining the group. Sex person; 2) Chronic gastritis refers to those diagnosed by gastroscopy within 3 months before joining the group); 3. Meet the diagnostic criteria of spleen deficiency and qi stagnation syndrome in traditional Chinese medicine; 4. Never received formal Hp eradication treatment (initial treatment); 5. Liver, kidney and heart functions are normal within 3 months (urine routine, blood biochemistry and electrocardiogram are normal); 6. I have taken amoxicillin and tetracycline orally in the past and have no adverse reactions such as allergies, if I am not sure whether I am allergic. Penicillin skin test should be negative; 7. Those who agree to participate in this experiment and sign the informed consent form: 8. Those who can participate in all the tests until the test is completed.

Exclusion criteria

Exclusion criteria: 1. Those who have used antibiotics, bismuth or PPI within 4 weeks before treatment; 2. Pregnant or lactating women; 3. Chinese medicine diagnosed that the constitution is stomach yin deficiency; 4. Patients with other serious diseases that affect the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumor or alcoholism; 5. Those who are allergic to the drugs used in this study or their components; 6. Participated in other drug research within 3 months before using the research drug; 7. Gastroscope suggests that besides gastritis, gastric ulcer and/or duodenal ulcer, or reflux esophagitis and other situations in which PPI or bismuth must continue to be taken after eradication of Helicobacter pylori; 8. Patients can't correctly express their chief complaints, such as psychosis and severe neurosis, and can't cooperate with the experimenter; 9. Other circumstances that the researcher considers inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Eradication rate of helicobacter pylori;

Secondary

MeasureTime frame
Remission rate of clinical symptoms;

Countries

China

Contacts

Public ContactFulian Hu

Peking University First Hospital

djjyhu@163.com13651136860

Outcome results

None listed

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