Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Study Overview
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Brief Summary
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To explore the efficacy and safety of Manpixiao in the treatment of Chronic Atrophic Gastritis.

Official Title
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Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Conditions
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Chronic Atrophic Gastritis

Intervention / Treatment
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* Drug: Manpixiao
* Drug: Active comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age is 18-75 years old, regardless of gender; Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai); Sign the informed consent form. Exclusion Criteria: Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases; Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors; Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years; Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes; Patients with chronic liver and kidney dysfunction before treatment, including ALT > 1.5 times the upper limit of normal value, blood creatinine (CR) > 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value; Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities); The description of self symptoms is unclear or the investigation is not the author; Have a history of alcohol abuse; Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug); Pregnant or lactating women; According to the judgment of the researcher, other reasons should not be selected.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manpixiao treatment group<br>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 | Drug: Manpixiao<br>* A traditional Chinese medicine composition<br>|
| No Intervention: Blank treatment group<br> | |
| Active Comparator: Active comparator<br>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. | Drug: Active comparator<br>* Other drugs that may have therapeutic effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |