To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).

Detailed Description
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Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.

Official Title
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A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis

Conditions
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Chronic Atrophic Gastritis (CAG)

Intervention / Treatment
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* Drug: Gastropylor Complex Capsules
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years, male or female Histologically diagnosed CAG HP negative confirmed by gastric mucosal staining Signed an written informed consent Exclusion Criteria: CAG with high-grade intraepithelial neoplasia Severe gastric mucosal erosion or bleeding needing treatment Active peptic ulcer, GERD, or esophageal stricture History of upper GI tract surgery History of malignant diseases With depression, anxiety neuroses, or hysteria Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L) Uncontrolled hypertension Uncontrolled diabetes Alcohol abuse Drug allergy Participated in another investigational study within 4 weeks prior to Visit 0 Pregnancy, be a nursing mother or without conception control There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo Comparator<br>* Placebo that is same as gastropyloric complex capsules<br>* Other names: Placebo;|
| Active Comparator: Gastropyloric Complex Capsules<br> | Drug: Gastropylor Complex Capsules<br>* 3 pills, three times a day, after meal<br>* Other names: Gastropyloric Extracts and Vit B12 Complex Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate confirmed by histology | All patients are required to repeat the histology examination after 180 days follow-up is completed. | within 180 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching |  | within 180 days after treatment |