Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients

Study Overview
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Brief Summary
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The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.

Official Title
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A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients

Conditions
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Acute Gastritis, Chronic Gastritis

Intervention / Treatment
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* Drug: Eupasidin-s Tab
* Drug: Stillen Tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is 19 years old and over, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms Patients with one or more erosions found by gastroscopy Patients who voluntarily signed written informed consent may participate in the study Exclusion Criteria: Patients with peptic ulcer and gastroesophageal reflux disease Patients with Gastrointestinal malignant tumor or surgery related to stomach resection Patients with thromboembolism and coagulation disorder Patients with significant cardiovascular, pulmonary, heptic, renal primary disease Patients with abnormal laboratory result at screening Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine > upper limit of normal range x 2 White blood cell(WBC) < 4,000/mm3 Platelet < 50,000/mm3 Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks History of allergic reaction to the investigational product Women either pregnant, breast feeding or possible to pregnant without contraceptive method Use of other investigational drugs within 3 months prior to the study Patients that investigators consider ineligible for this study

Ages Eligible for Study
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Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eupasidin-s tab.<br>three times per day, 1 tab for each time, PO, during 2weeks | Drug: Eupasidin-s Tab<br>* three times per day, 1 tab for each time, PO, during 2weeks<br>* Other names: Artemisia herb isopropanol soft ext. 60mg;|
| Active Comparator: Stillen tab.<br>three times per day, 1 tab for each time, PO, during 2weeks | Drug: Stillen Tab.<br>* three times per day, 1 tab for each time, PO, during 2weeks<br>* Other names: Artemisia asiatica 95% ethanol ext. 60mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate of erosion |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement rate of erosion |  | 2 weeks | 
| improvement rate of erythema |  | 2 weeks | 
| improvement rate of hemorrhage |  | 2 weeks | 
| improvement rate of edema |  | 2 weeks | 
| improvement rate of self symptoms |  | 2 weeks |