esophageal precancerous lesions
Conditions
Interventions
Experimental Group:Shun Qi Dao Tan Kai Ye Decoction
Control Group:Shun Qi Dao Tan Kai Ye Decoction Simulator
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Gastroscopy and pathological examination results within 1 year meet the diagnostic criteria for diagnosis of low-grade intraepithelial neoplasia of esophageal squamous epithelium or Barrett's esophagus with low-grade dysplasia; 2: Meet the diagnostic criteria for Qi stagnation and phlegm obstruction syndrome in traditional Chinese medicine; 3: Age 18~75 years (including endpoint values), gender; 4: Voluntarily participate in this study and sign or have the legal representative sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Patients with high-grade intraepithelial neoplasia of esophageal squamous epithelium or those with risk factors for pathological upgrading, patients with Barrett's esophagus accompanied by high-grade intraepithelial neoplasia, or those with suspected malignancy based on pathological diagnosis; 2: Patients with severe cardiovascular, cerebrovascular, thyroid, hepatic, renal, hematological, or respiratory system diseases, or malignant tumors; 3: Patients with laboratory findings indicating abnormal liver or kidney function, including ALT > 1.5 times the upper limit of normal, AST > 1.5 times the upper limit of normal, or Scr > upper limit of normal, with any one of these criteria excluding participation; 4: Depressed patients: HAMD depression scale score = 18 points; 5: Anxious patients: HAMA anxiety scale score = 14 points; 6: Patients with mental disorders or intellectual and language impairments; 7: Pregnant or breastfeeding women; 8: Patients allergic to the components of this preparation or its excipients; 9: Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks; 10: Patients with suspected or confirmed history of alcohol or substance abuse; 11: Patients with other conditions, as judged by the investigator, that may reduce the likelihood of enrollment or complicate the enrollment process, such as those with frequently changing work environments that may lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer transformation rate;Pathological downgrading rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The area and number of esophageal lesions under endoscopy.;Micromorphological changes;TCM Syndrome Score;Quality of Life Rating; | — |
Countries
China
Contacts
Public ContactHuangshao Gang
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed