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The goal of this clinical trial is to investigate the efficacy and safety of Weifuchun tablet in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. The main questions it aims to answer are: Does Weifuchun tablet promote the regression of gastric intestinal metaplasia in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Weifuchun tablet? Researchers will compare the effectiveness of Weifuchun tablet in treating gastric intestinal metaplasia with that of folic acid, as suggested by the Chinese consensus on management of gastric epithelial precancerous conditions and lesions (2020). Participants will: Take Weifuchun tablets or folic acid every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Weifuchun tablet group | Experimental | Patients in the Weifuchun tablet group will receive oral Weifuchun tablet at a dosage of 1400 mg three times daily for 6 months. |
|
| The folic acid group | Active Comparator | Patients in the folic acid group will receive oral folic acid at a dosage of 5 mg three times daily for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weifuchun | Drug | Subjects will be instructed to take four tablets (1400mg) of Weifuchun three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication. |
| Measure | Description | Time Frame |
|---|---|---|
| The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | Regression was defined as a OLGIM stage decreased at least one grade. | From enrollment to the end of treatment at 6 months. |
| The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | Progression was defined as a OLGIM stage increased at least one grade. | From enrollment to the end of treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The regression rate of gastric atrophy based on OLGA stage in different groups. | Regression was defined as a OLGA stage decreased at least one grade. | From enrollment to the end of treatment at 6 months. |
| The progression rate of gastric atrophy based on OLGA stage in different groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi | Contact | 0086 + 02984771515 | shiyquan@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Recruiting | Xi'an | 710032 | China |
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| ID | Term |
|---|---|
| C000708357 | weifuchun |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Folic Acid | Drug | Subjects will be instructed to take one tablet (5mg) of folic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication. |
|
Progression was defined as a OLGA stage increased at least one grade. |
| From enrollment to the end of treatment at 6 months. |
| D006571 | Heterocyclic Compounds |