esophageal precancerous lesions
Conditions
Interventions
treatment group:Huatan Sanyu Tongye Decoction
control group:Huatan Sanyu Tongye Decoction Placebo
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The gastroscopy and pathological examination results within 2 months before participating in this study meet the Western diagnostic criteria for low-grade squamous intraepithelial neoplasia or Barrett's esophagus with low-grade dysplasia; 2. Meet the diagnostic criteria for the phlegm-blood stasis syndrome in traditional Chinese medicine; 3. Aged 18 to 75 (inclusive), with no gender restrictions; 4. Volunteer to participate in this study and sign or have a legal guardian sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with esophageal squamous epithelium accompanied by high-grade dysplasia or risk factors for pathological upgrading, Barrett's esophagus accompanied by high-grade dysplasia, or suspected malignant transformation based on pathological diagnosis; 2. Patients with serious cardiovascular, cerebrovascular, thyroid, liver, kidney, blood, respiratory system diseases or malignant tumors; 3. Laboratory tests indicate abnormal liver and kidney function, with ALT>1.5 times the upper limit of normal values, AST>1.5 times the upper limit of normal values, and Scr>the upper limit of normal values. If any of these conditions are met, they are excluded; 4. Patients with moderate depression: HAMD Depression Scale score = 18 points; 5. Patients with moderate anxiety: HAMA anxiety scale score = 14 points; 6. Patients with mental illnesses and those with intellectual and language disabilities; 7. Pregnant or lactating women or patients planning to conceive in the near future; 8. Those who are allergic to the ingredients or excipients of this preparation; 9. Patients who have participated or are currently participating in other clinical trials within the previous 4 weeks of participating in this study; 10. Suspect or have a history of alcohol or drug abuse; 11. Other circumstances that may reduce the likelihood of inclusion or complicate inclusion, such as frequent changes in the work environment, based on the researcher's judgment, may lead to loss to follow-up for patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological outcome assessment of esophageal mucosal intraepithelial neoplasia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of esophageal lesion area under endoscopy;Clinical symptom score;Morphological changes of capillary loops in esophageal epithelial papilla;Changes in biomarkers;EQ-5D-5L Score; | — |
Countries
China
Contacts
Public ContactBingduo Zhou
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed