Skip to main content
OpenTrials
Completed

NCT Number: NCT02356679

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inje University Busanpaik hospital, Busan, Busangjin, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eupasidin-s Tab

Drug

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

Other names: Artemisia herb isopropanol soft ext. 60mg

Stillen Tab.

Drug

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

Other names: Artemisia asiatica 95% ethanol ext. 60mg

Primary outcomes

  1. cure rate of erosion

    Time frame: 2 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2015
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.