NCT02356679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

September 2, 2014

Last Update Submit

August 21, 2015

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • cure rate of erosion

    2 weeks

Secondary Outcomes (5)

  • 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

Study Arms (2)

Eupasidin-s tab.

EXPERIMENTAL

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

Drug: Eupasidin-s Tab

Stillen tab.

ACTIVE COMPARATOR

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

Drug: Stillen Tab.

Interventions

Eupasidin-s TabDRUG

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

Also known as: Artemisia herb isopropanol soft ext. 60mg
Eupasidin-s tab.
Stillen Tab.DRUG

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

Also known as: Artemisia asiatica 95% ethanol ext. 60mg
Stillen tab.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Inje University Busanpaik hospital

Busan, Busangjin, 614-735, South Korea

Location

Chonbuk National University Hospital

Jeonju, Deokjin-gu, 561-712, South Korea

Location

Chonnam National University Hospital

Guangju, Dong-gu, 501-757, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Ilsan-ro, 220-701, South Korea

Location

Chungnam National University Hospital

Daejeon, Jung-gu, 301-721, South Korea

Location

Wonkwang University School of Medicine & Hospital

Iksan, Muwang-ro, 570-711, South Korea

Location

Yeungnam University Medical Center

Daegu, Nam-gu, 705-703, South Korea

Location

Kosin University Gospel Hospital

Busan, Seo-gu, 602-702, South Korea

Location

Dong-A University Hospital

Busan, Seo-gu, 602-812, South Korea

Location

Hanyang University Medical Center

Seoul, Seongdong-gu, 133-792, South Korea

Location

MeSH Terms

Interventions

DA 9601

Study Officials

  • Sangyong Seol, Professor

    Inje University Busanpaik Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

February 5, 2015

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

KR(10)