Chronic atrophic gastritis with low grade dysplasia
Conditions
Interventions
control group:The simulator of Shenye Xiaozhen Decoction
experimental group:Shenye Xiaozhen Decoction
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study a subject must meet all of the following criteria: 1)Diagnosed as chronic atrophic gastritis with low-grade dysplasia by both endoscopic and pathological diagnostic criteria. 2)TCM syndrome differentiation belongs to the syndrome of liver depression and blood stasis. 3)Age is ranged between35 and 70 years old regardless of gender. 4)Voluntarily signed informed consent and could cooperate with corresponding treatment and follow-up. PS. All subjects must be tested for Helicobacter pylori (Hp) 13C breath test before enrollment. If positive quadruple drug therapy as recommended in treatment guidelines should be given. After treatment no matter the outcome subjects can directly be enrolled in the trial and TCM syndrome score of the subject should be re-evaluated
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1)Autoimmune gastritis. 2)High-grade intraepithelial neoplasia in gastric mucosa or pathological diagnosis is suspected malignancy. 3)Chronic atrophic gastritis with clear boundaries of low-grade dysplasia observed endoscopically. 4)Peptic or duodenal ulcer disease or upper gastrointestinal hemorrhage. 5)Gastric surgery history. 6)Long-term use of NSAIDsPPIsH2RAs. 7)Serious primary diseases of the heart brain liver kidney lung or(and) blood system or malignant tumors. 8)Moderate to severe anxiety depression or other mental illness as well as intellectual and language impairments. 9)Pregnant or lactating women(Female subjects are required to use contraception). 10)Allergic constitution or being allergic to the drugs used in this study. 11) Enrollment in other clinical study within the last 3 months before screening. 12) Other conditions deemed unsuitable for inclusion by the researchers. PS. The anxiety and depression status of the subjects are evaluated by the researchers according to the HAMA and HAMD scales.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| histopathological reversal rate of dysplasia;histopathological progression rate of dysplasia; | — |
Secondary
| Measure | Time frame |
|---|---|
| serological indicator(G-17\PGR and so on);endoscopic gastric cancer risk score;TCM syndrome score;OLGA/OLGIM; | — |
Countries
China
Contacts
Public ContactShiRui
Beijing University of Chinese Medicine
Outcome results
None listed