## Protocol Section
### Identification Module
**NCT ID:** NCT02356679

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

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

#### Organization Study ID Info
**ID:** EUPASIDIN-S_P4
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-08-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-08-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Start Date
**Date:** 2014-08

**Status Verified Date:** 2015-08

#### Study First Post Date
**Date:** 2015-02-05
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-02
**Study First Submit QC Date:** 2015-02-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chong Kun Dang Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Acute Gastritis

- Chronic Gastritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 230

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Eupasidin-s Tab

**Label:** Eupasidin-s tab.

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Stillen Tab.

**Label:** Stillen tab.

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Eupasidin-s tab.

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

**Name:** Eupasidin-s Tab

**Other Names:**

- Artemisia herb isopropanol soft ext. 60mg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Stillen tab.

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

**Name:** Stillen Tab.

**Other Names:**

- Artemisia asiatica 95% ethanol ext. 60mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** cure rate of erosion

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Measure:** improvement rate of erosion

**Time Frame:** 2 weeks

**Measure:** improvement rate of erythema

**Time Frame:** 2 weeks

**Measure:** improvement rate of hemorrhage

**Time Frame:** 2 weeks

**Measure:** improvement rate of edema

**Time Frame:** 2 weeks

**Measure:** improvement rate of self symptoms

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Inje University Busanpaik hospital

**State:** Busangjin

**Zip:** 614-735

**Location 2:**

**City:** Jeonju

**Country:** Korea, Republic of

**Facility:** Chonbuk National University Hospital

**State:** Deokjin-gu

**Zip:** 561-712

**Location 3:**

**City:** Guangju

**Country:** Korea, Republic of

**Facility:** Chonnam National University Hospital

**State:** Dong-gu

**Zip:** 501-757

**Location 4:**

**City:** Wonju

**Country:** Korea, Republic of

**Facility:** Wonju Severance Christian Hospital

**State:** Ilsan-ro

**Zip:** 220-701

**Location 5:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Chungnam National University Hospital

**State:** Jung-gu

**Zip:** 301-721

**Location 6:**

**City:** Iksan

**Country:** Korea, Republic of

**Facility:** Wonkwang University School of Medicine & Hospital

**State:** Muwang-ro

**Zip:** 570-711

**Location 7:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Yeungnam University Medical Center

**State:** Nam-gu

**Zip:** 705-703

**Location 8:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Kosin University Gospel Hospital

**State:** Seo-gu

**Zip:** 602-702

**Location 9:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Dong-A University Hospital

**State:** Seo-gu

**Zip:** 602-812

**Location 10:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Hanyang University Medical Center

**State:** Seongdong-gu

**Zip:** 133-792

#### Overall Officials

**Official 1:**

**Affiliation:** Inje University Busanpaik Hospital

**Name:** Sangyong Seol, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8872

- Name: Gastritis

- Relevance: HIGH

- As Found: Gastritis

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005756

- Term: Gastritis

### Intervention Browse Module - Ancestors

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: HIGH

- As Found: Dependent

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

- ID: T232

- Name: Mugwort

- Relevance: HIGH

- As Found: Messenger

- ID: T327

- Name: Wormwood

- Relevance: HIGH

- As Found: Messenger

### Intervention Browse Module - Meshes

- ID: D000000431

- Term: Ethanol

### Misc Info Module

- Version Holder: 2024-05-24
