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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02356679
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Acute Gastritis Chronic Gastritis Drug: Eupasidin-s Tab Drug: Stillen Tab. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Eupasidin-s tab.
three times per day, 1 tab for each time, PO, during 2weeks
Drug: Eupasidin-s Tab
three times per day, 1 tab for each time, PO, during 2weeks
Other Name: Artemisia herb isopropanol soft ext. 60mg

Active Comparator: Stillen tab.
three times per day, 1 tab for each time, PO, during 2weeks
Drug: Stillen Tab.
three times per day, 1 tab for each time, PO, during 2weeks
Other Name: Artemisia asiatica 95% ethanol ext. 60mg




Primary Outcome Measures :
  1. cure rate of erosion [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. improvement rate of erosion [ Time Frame: 2 weeks ]
  2. improvement rate of erythema [ Time Frame: 2 weeks ]
  3. improvement rate of hemorrhage [ Time Frame: 2 weeks ]
  4. improvement rate of edema [ Time Frame: 2 weeks ]
  5. improvement rate of self symptoms [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356679


Locations
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Korea, Republic of
Inje University Busanpaik hospital
Busan, Busangjin, Korea, Republic of, 614-735
Chonbuk National University Hospital
Jeonju, Deokjin-gu, Korea, Republic of, 561-712
Chonnam National University Hospital
Guangju, Dong-gu, Korea, Republic of, 501-757
Wonju Severance Christian Hospital
Wonju, Ilsan-ro, Korea, Republic of, 220-701
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 301-721
Wonkwang University School of Medicine & Hospital
Iksan, Muwang-ro, Korea, Republic of, 570-711
Yeungnam University Medical Center
Daegu, Nam-gu, Korea, Republic of, 705-703
Kosin University Gospel Hospital
Busan, Seo-gu, Korea, Republic of, 602-702
Dong-A University Hospital
Busan, Seo-gu, Korea, Republic of, 602-812
Hanyang University Medical Center
Seoul, Seongdong-gu, Korea, Republic of, 133-792
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Sangyong Seol, Professor Inje University Busanpaik Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02356679    
Other Study ID Numbers: EUPASIDIN-S_P4
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs