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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06340724
Other study ID # KY20240123-08
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date March 2024
Est. completion date March 2025

Study information

Verified date March 2024
Source Nanjing First Hospital, Nanjing Medical University
Contact Wenjuan Wei, Doctorate
Phone +8618851009006
Email wjwei.hf@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.


Description:

Helicobacter pylori(H.pylori)is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 18-65 years old 2. Patients with H.pylori infection 3. Diagnosed as functional dyspepsia 4. Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine. 5. Patients who have not received H. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months. 6. Volunteer to participate in this experiment and sign the informed consent. Exclusion Criteria: 1. Allergy to research drugs (penicillin allergy, etc.) 2. Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases. 3. Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases 4. Patients who have received H. pylori eradication treatment within six months. 5. Antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine H2 receptor antagonist or PPI was used 2 weeks before the start of study treatment. 6. Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants. 7. History of esophageal or gastric surgery 8. Pregnant and lactating women

Study Design


Intervention

Drug:
Vonoprazan
20 mg tablet twice daily
Amoxicillin
1 g tablet three times daily
Banxiaxiexin decotion
100 ml liquid-medicine twice daily

Locations

Country Name City State
China Nanjing First Hospitai Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in functional dyspepsia symptoms at 6 weeks Functional dyspepsia symptoms on days 7,14,28 and 42 were assessed using Likert scale Baseline and Week 6
Primary Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks Traditional Chinese Medicine syndromes on days 7,14,28 and 42 were assessed using TCM syndrome integral scale Baseline and Week 6
Secondary Adverse reactions that occur after taking medication The patients were followed up by telephone on the days 7 and 14 day 1 and day 14
Secondary Patients' drug compliance Patients' drug compliance was assessed using medication possession ratio day 1 and day 14
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