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

NCT ID: NCT02356679

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Gastritis Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stillen tab.

three times per day, 1 tab for each time, PO, during 2weeks

Group Type ACTIVE_COMPARATOR

Stillen Tab.

Intervention Type DRUG

three times per day, 1 tab for each time, PO, during 2weeks

Eupasidin-s tab.

three times per day, 1 tab for each time, PO, during 2weeks

Group Type EXPERIMENTAL

Eupasidin-s Tab

Intervention Type DRUG

three times per day, 1 tab for each time, PO, during 2weeks

Interventions

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Eupasidin-s Tab

three times per day, 1 tab for each time, PO, during 2weeks

Intervention Type DRUG

Stillen Tab.

three times per day, 1 tab for each time, PO, during 2weeks

Intervention Type DRUG

Other Intervention Names

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Artemisia herb isopropanol soft ext. 60mg Artemisia asiatica 95% ethanol ext. 60mg

Eligibility Criteria

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Inclusion Criteria

1. Age is 19 years old and over, men or women
2. Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
3. Patients with one or more erosions found by gastroscopy
4. Patients who voluntarily signed written informed consent may participate in the study

Exclusion Criteria

1. Patients with peptic ulcer and gastroesophageal reflux disease
2. Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
3. Patients with thromboembolism and coagulation disorder
4. Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
5. 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
6. 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
7. History of allergic reaction to the investigational product
8. Women either pregnant, breast feeding or possible to pregnant without contraceptive method
9. Use of other investigational drugs within 3 months prior to the study
10. Patients that investigators consider ineligible for this study
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangyong Seol, Professor

Role: PRINCIPAL_INVESTIGATOR

Inje University Busanpaik Hospital

Locations

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Inje University Busanpaik hospital

Busan, Busangjin, South Korea

Site Status

Chonbuk National University Hospital

Jeonju, Deokjin-gu, South Korea

Site Status

Chonnam National University Hospital

Guangju, Dong-gu, South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, Ilsan-ro, South Korea

Site Status

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Site Status

Wonkwang University School of Medicine & Hospital

Iksan, Muwang-ro, South Korea

Site Status

Yeungnam University Medical Center

Daegu, Nam-gu, South Korea

Site Status

Kosin University Gospel Hospital

Busan, Seo-gu, South Korea

Site Status

Dong-A University Hospital

Busan, Seo-gu, South Korea

Site Status

Hanyang University Medical Center

Seoul, Seongdong-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EUPASIDIN-S_P4

Identifier Type: -

Identifier Source: org_study_id

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