Status:
UNKNOWN
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Beijing Friendship Hospital
Conditions:
Gastric Precancerous Condition
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology...
Detailed Description
Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer. However, no universally acknowledged effectiv...
Eligibility Criteria
Inclusion
- Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
- Patients aged from 18-75 years;
- Subjects who were informed and voluntarily signed the informed consent.
Exclusion
- Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
- Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
- Patients taking NSAIDs for a long term;
- Patients suspected of gastric cancer or malignant lesions in other systems;
- Patients with a history of gastric surgery;
- Patients with concurrent primary diseases in cardiovascular, cerebrovascular, liver, kidney and hemopoietic systems (ALT\>80 u/L, and/or AST\>80 u/L, with abnormal renal function)
- Patients with mental disease, dysgnosia and logopathy;
- Pregnant women, or those preparing a pregnancy and breastfeeding women;
- Patients with a allergic history of medicines used in this experiment.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT03823248
Start Date
March 1 2019
End Date
December 31 2021
Last Update
June 25 2021
Active Locations (1)
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1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China, 100091