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To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manpixiao treatment group | Experimental | A traditional Chinese medicine composition (has applied for Chinese patent),Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks |
|
| Blank treatment group | No Intervention | ||
| Active comparator | Active Comparator | Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manpixiao | Drug | A traditional Chinese medicine composition |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological improvement rate of gastric mucosa | Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy | The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric mucosal status under gastroscope | For the color of gastric mucosa, spots, erosion, bleeding, reduced folds, visible blood vessels and mucosal texture, 0, 1, 2 and 3 points are given according to the levels of none, I, II and III respectively, and 0 and 1 points are given according to the presence or absence of bile reflux. According to the gastroscopy report, score the patients' microscopic results before and after treatment, and take the result change as the secondary index of curative effect. A lower score means a better result. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongfang Hospital, Beijing University of Chinese Medicine | Recruiting | Beijing | China |
Obtained by asking the first or correspondent author if necessary
One year after the completion of the study
Obtained by asking the first or correspondent author if necessary
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 26, 2021 | Aug 5, 2022 | Prot_SAP_ICF_000.pdf |
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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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| Active comparator |
| Drug |
Other drugs that may have therapeutic effects |
|
| The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment. |
| Score of main symptoms of stomach system | Adopt the "table of main symptoms of stomach system based on doctor's report", the specific contents are: epigastric (epigastric) pain, epigastric (epigastric) distension, epigastric (epigastric) blockage, heartburn, acid reflux, belching, anorexia, reduced appetite. Score 0, 1, 2 and 3 points for the severity of each single symptom (none, mild, moderate and severe). The total score of symptoms is the sum of the individual scores. By comparing the changes of individual symptom scores and total symptom scores between groups, lower scores mean better results. | They were evaluated on the day of enrollment and the day of the end of the treatment process |
| Dongzhimen Hospital, Beijing University of TCM | Recruiting | Beijing | China |
|
| Zaozhuang Hospital, Beijing University of Chinese Medicine | Recruiting | Beijing | China |
|
| D013272 |
| Stomach Diseases |