Gastric precancerous lesions against the background of atrophic gastritis
Conditions
Interventions
control group:Chinese medicine granule simulator: 1 sachet each time 3 times a day taken orally 1 hour after meals. Folic acid tablets: 5mg each time 3 times a day taken orally half an hour after meal
Experimental group:Chinese medicine granules: 1 sachet each time, 3 times a day, taken orally 1 hour after meals. Folic acid tablet simulator: 5mg each time, 3 times a day, taken orally half an hour a
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Those who have been diagnosed with chronic atrophic gastritis accompanied by low-grade dysplasia or indefinite dysplasia via gastroscopy and pathological examination within the recent 6 months (gastroscopy and pathological examination results must be provided); 2)aged between 30 and 70 years old (inclusive of the endpoints) with no restriction on gender; 3)subjects who are informed voluntarily participate in this study and have signed the informed consent form or have it signed by their legal representatives.
Exclusion criteria
Exclusion criteria: 1) Suspected gastric cancer high-grade dysplasia peptic ulcer erosive gastritis (grade 2 or above) etc. confirmed by gastroscopy and histopathological examination; 2) Those who are currently using or need to continuously use drugs that have a protective effect on gastric mucosa or affect gastrointestinal function or need long-term use of non-steroidal anti-inflammatory drugs; 3) Those with severe diseases in the cardiovascular cerebrovascular thyroid liver kidney blood respiratory and other systems or malignant tumors; 4) Patients with moderate to severe anxiety or depression; 5) Patients with mental illness and those with intellectual or language disorders; 6) Those with abnormal liver or kidney function indicated by laboratory tests with ALT > 1.5 times the upper limit of normal value AST > 1.5 times the upper limit of normal value or Scr > upper limit of normal value (any of these conditions is an exclusion criterion); 7) Patients who are currently participating in other drug clinical trials or have participated in such trials within 4 weeks; 8) Those with suspected or confirmed history of alcohol or drug abuse; 9) Patients allergic to folic acid its metabolites Chinese medicinal ingredients in Yiqi Huayu Jiedu Decoction and other drugs; 10) Other circumstances that in the investigator's judgment may reduce the possibility of enrollment or complicate enrollment such as patients with frequent changes in work environment that may easily lead to loss of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semi-quantitative evaluation score of dysplasia;Histopathological evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome scores and effective rates;Score and response rate of background mucosal lesions (atrophy/intestinal metaplasia);Pepsinogen?;Pepsinogen?;Gastroscopic mucosal lesion score;Histopathological immunohistochemical detection;Gastrin-17;Clinical symptom scores and response rates; | — |
Countries
China
Contacts
Public ContactPing Wang
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed