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This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation group and Weifuchun routine treatment as the control group, so as to provide evidence for the treatment of CAG and reduce the risk of gastric cancer. A total of 284 patients were included. The curative efficacy, symptom score and adverse events will be recorded and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MLD | Modified Liujunzi Decoction,1 package twice daily,6 months |
| |
| WFC | Weifuchun,three times a day, four at a time,6months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLD | Drug | Modified Liujunzi Decoction is provided by the chinese pharmacy of Peking University First Hospital , one dose per day, taken in twice, and the course of treatment is 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effectiveness of gastric mucosal lesions | Referring to the CAG of the "Guidelines for Clinical Research on New Chinese Medicines (2002)", the effective treatment of gastric mucosal lesions is defined as "the pathological score decreased by 1 point compared with the previous point". The effective rate of gastric mucosal lesions treatment = the number of cases with a decrease of ≥ 1 point by the previous score / the total number of cases × 100%. The effective rate of gastric mucosal lesions from different category will be calculated: respectively for atrophy, chronic inflammation, activity, intestinal metaplasia, and intraepithelial neoplasia . | Half a year,a year |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of OLGA,OLGIM | The efficacy of OLGA staging: OLGA staging decreased by ≥1 stage compared with the baseline is considered as effecacy.The effective rate = the number of cases with ≥1 stage decreased compared with the previous stage/the total number of cases × 100%. The efficacy of OLGIM staging:The OLGIM staging decreased by ≥1 stage from the baseline is considered effective for patients with intestinal metaplasia. The effective rate = the number of cases staging decreased by ≥ 1 stage compared with the previous stage /the total number of cases × 100% |
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Inclusion Criteria:
Exclusion Criteria:
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According to the willingness of the patients, the CAG patients after HP eradication in the routine diagnosis and treatment of the Department of integrated traditional Chinese and Western medicine and the Department of Gastroenterology of the Peking University First Hospital were enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiuyue Huang, doctor | Contact | +86010 83572351 | 803 | 1711210349@pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Blood;Biopsy specimen of gastric mucosa
| WFC | Drug | Chinese patent medicine, take according to the instructions, the course of treatment is 6 months. |
|
| Half a year,a year |
| Changes in clinical symptom scores | Evaluate referring to the symptom grading and quantification standard of "Guidelines for Clinical Research on Chronic Atrophic Gastritis" from "Guidelines for Clinical Research on New Chinese Medicines (2002)".According to the clinical symptom severity assign different points. No, mild, moderate and severe symptoms are recorded as 0, 1, 2, and 3 point respectively. Record the changes of the symptom score at 6 months and 12 months compared with the baseline and evaluate . The calculation formula is " the total score after treatment-the score in baseline ". | The third month,half a year ,the ninth month,a year. |
| The recurrence of HP | 13C-UBT was performed to determine HP, and the DOB value more than 4 is defined as the recurrence of HP. | Half a year,a year |
| D013272 |
| Stomach Diseases |