Barrett's esophagus
Conditions
Interventions
Part I Control Group:Jiangni Xiaodan Formula Granules Placebo + Esomeprazole Magnesium Enteric Capsules
Part I Pilot Group:Jiangni Xiaodan Formula Granules + Esomeprazole Magnesium Enteric Capsules
Part II BE control group:Jiangni Xiaodan Formula Granules Placebo + Esomeprazole Magnesium Enteric Capsules
Part II Non-BE Control Subjects:No drug interventions
Part II BE Pilot Group:Jiangni Xiaodan Formula Granules + Esomeprazole Magnesium Enteric Capsules
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. BE subjects: 1) Meet the diagnostic criteria of BE; 2) Discontinue the use of acid-suppressing agents such as PPI agents and H2 receptor antagonists, non-zithromycin anti-inflammatory drugs, inhibitors and UDCA for more than four weeks prior to the study; 3) Age =18 and =70 years old, gender is not limited; 4) Signed the informed consent form. 2. Non-BE control subjects: 1) liver and kidney function, blood, urine and stool routine, electrocardiography, gastroscopy results within the normal range, no reflux esophagitis, BE, non-erosive gastroesophageal reflux disease and other esophageal diseases, and there is no other functional or organic diseases; 2) do not need to take drugs on a regular basis, and there is no history of drug abuse; 3) age = 18 years old and = 70 years old, gender is not limited; 4) signed informed consent. consent form.
Exclusion criteria
Exclusion criteria: 1. BE subjects: 1) those with a history of BE and histologically confirmed low-grade atypical hyperplasia, high-grade atypical hyperplasia or adenocarcinoma; 2) those with a history of gastric or esophageal surgery (including those who have previously undergone endoscopic treatment for BE); 3) those with a combination of peptic ulcers, malignant lesions of the upper gastrointestinal tract, history of gastroesophageal and duodenal surgeries, drug-induced esophagitis, and the Zollinger-Ellison sign; 4) those with pregnancy or lactation; 5) those with mental illness and other patients who are unable to describe their symptoms or understand their symptoms. Pregnant women or breastfeeding women; 5) Patients with mental illness and other patients who are unable to self-describe their symptoms or have comprehension disorders. 2. Non-BE control subjects: 1) Combined heart, brain, liver, kidney, urinary, gastrointestinal, reproductive system and other serious diseases; 2) pregnant or lactating women; 3) mental illness and other patients who can not self-describe the symptoms, understanding of the obstacles; 4) is participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Histopathological observation of lesions;Comparison of esophageal lesion area;Comparison of Chinese medicine evidence points;Immunohistochemistry of core targets in diseased tissue; | — |
Countries
China
Contacts
Public Contactwangxiaosu
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed