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Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuzhegn Nizeng Formula | Experimental |
| |
| Moluodan patient medicine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuzhegn Nizeng Decoction | Drug | Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate of Low-grade Intraepithelial Neoplasia | Stomach biopsy will be taken after drug administration completion. | The 180 days after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-point Global Overall Symptom Scale | Dyspepsia symptoms will be recorded and evaluated by 7-point Global Overall Symptom Scale | 1st, 2nd, 3rd, 4th, 5th, 6th month |
| Adverse event rate | Any adverse event will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Moluodan granules | Drug | Subjects taking prepared Moluodan granules 9g twice daily for 6 month. |
|
| The 6 months during the drug administration |
| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| D002278 | Carcinoma in Situ |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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