None listed
Conditions
Interventions
control group:Pantoprazole+colloidal bismuth pectin+amoxicillin+clarithromycin
Test group:Kapulasheng+colloidal bismuth pectin+amoxicillin+clarithromycin
Sponsors
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Nankai Hospital, Tianjin)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria of Hp positivity (DOB>4) determined by C13 breath test; (2) Age range of 18-65 years old (including boundary values), gender not limited; (3) Individuals who deny a history of drug sensitivity and test negative for penicillin skin test; (4) After fully understanding this study, voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Individuals known to have a history of allergies to Kapilasheng tablets or pantoprazole, or to related excipients of Kapilasheng tablets or pantoprazole enteric coated capsules, such as mannitol, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, hydroxypropyl cellulose, magnesium stearate, and film coating agents; ? Subjects who have previously undergone endoscopic examination and have been found to have other esophageal organic lesions in addition to chronic gastritis; ? Patients with combined rheumatic and immune diseases (such as scleroderma, undifferentiated connective tissue disease, etc.), or those with a history of esophageal radiotherapy or esophageal cryotherapy; ? Subjects with active peptic ulcers, suspected or diagnosed malignant tumors detected during gastrointestinal endoscopy examination; ? Screening for individuals with a history of malignant tumors within the past 5 years (if the subject's skin basal cell carcinoma or cervical carcinoma in situ has been cured, he/she can participate in this study); ? The subjects have severe central nervous system, cardiovascular, respiratory system, liver, kidney, gastrointestinal, urinary system, endocrine system or hematological diseases that the researchers believe may confuse the research results or affect the safety of the subjects; ? During the screening period, laboratory tests showed ALT or AST levels greater than 1.5 times the upper limit of normal, or renal function Cr levels greater than the upper limit of normal (the study allows for one follow-up examination, and those who still do not meet the inclusion requirements will be excluded); ? Long term use of systemic corticosteroids, immunosuppressants, and other medications by subjects prior to screening; ? Screening for individuals with a long-term history of drug abuse or alcohol abuse within the previous 6 months; ? Female participants who are pregnant, breastfeeding, or preparing for pregnancy during the trial period. According to the researchers' judgment, women of childbearing age who are unable to use medically recognized and reliable contraceptive methods for contraception within 4 weeks after the last dose of the study and after signing the informed consent form; ? Individuals who have participated in clinical studies of other drugs/devices and used the investigational drug/device within the first 3 months prior to randomization; ? Researchers believe that other participants are not suitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breath test to determine Hp; | — |
Countries
china
Contacts
Public Contactyanping tang
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Nankai Hospital, Tianjin)
Outcome results
None listed