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a multicenter randomized controlled clinical study on the prevention and treatment of esophageal precancerous lesions using the method of nourishing yin and clearing diaphragm

a multicenter randomized controlled clinical study on the prevention and treatment of esophageal precancerous lesions using the method of nourishing yin and clearing diaphragm

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000127
Enrollment
Unknown
Registered
2024-07-17
Start date
2024-07-30
Completion date
Unknown
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-cancerous lesions of esophageal cancer

Interventions

blank control group:Regular review of electronic endoscopy
intervention group:Taking Li Ge Di Huang Pills

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
cancer rate;

Secondary

MeasureTime frame
reversal rate;Symptomatic efficiency in TCM;Evaluation of the quality of life;

Countries

China

Contacts

Public ContactYanni Lou

China-Japan Friendship Hospital

1213860635@qq.com+86 186 0132 7716

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026