ITMCTR2024000127Not yet recruitingPhase 4
a multicenter randomized controlled clinical study on the prevention and treatment of esophageal precancerous lesions using the method of nourishing yin and clearing diaphragm
China-Japan Friendship Hospital0 sitesStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 45 to 75 (—)
- Sex
- All
Inclusion Criteria
- •1) low-grade intraepithelial neoplasia of esophageal squamous epithelium in the previous screening cohort of high incidence of esophageal cancer, and the pathologic diagnosis of low-grade intraepithelial neoplasia by endoscopic re-biopsy prior to enrollment; 2) the lesion measured =6mm under the endoscope at the time of endoscopic reexamination, and the scope of the lesion is still preserved after endoscopic bite examination (the diameter of the biopsy forceps operation was about 5mm, so to avoid the bias caused by biopsy operation) 3) Chinese medicine diagnosis meets the diagnostic criteria of Yin deficiency and dryness-heat syndrome; 4) Age =45 years and <75 years; 5) Able to understand the situation of this study, cooperate with regular endoscopic evaluation and follow-up, and sign the informed consent form.
Exclusion Criteria
- •1) People with esophago-gastric fundus varices, esophageal stenosis; 2) People with history of esophageal or gastric surgery; 3) People with serious abnormalities of vital organ function; 4) People with contraindications to gastroscopy and mucosal biopsy; 5) People with a history of hypersensitivity or intolerance to the study drugs or components; 6) People with a diagnosis of esophageal/gastric cancer or other malignant tumors; 7) People with a life expectancy of less than 5 years for other serious illnesses.
Investigators
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