A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495
NCT ID: NCT04255589
Last Updated: 2021-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2020-01-06
2021-05-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Artemisia and Green Tea Extracts for Gastric Mucosal Health
NCT06628804
Effects of Green Tea Extracts on Gastric Mucosal Protection
NCT04742985
Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
NCT00920712
Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori
NCT02803216
Effect of Gingest on Symptoms of Dyspepsia
NCT03548363
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Patients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab)
CKD-495 75mg
CKD-495 75mg Tab.
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
Active comparator Group
Patients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg)
Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
Placebo of the CKD-495 75mg
Placebo of the CKD-495 75mg Tab.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CKD-495 75mg
CKD-495 75mg Tab.
Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
Placebo of the CKD-495 75mg
Placebo of the CKD-495 75mg Tab.
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date
3. Patients who have more than 1 subjective symptom
Exclusion Criteria
2. Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis
3. Patients who have to take medicine that could cause gastritis
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oh Young Lee, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chonnam National University Hospital
Gwangju, Donggu, South Korea
Kyoungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Busan National University Hospital
Busan, Seo-gu, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Chung Ang University Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Yeouido ST. Mary's Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Seo SY, Lee ST, Kim SK, Chun HJ, Song GA, Lee DH, Kim JJ, Kim JI, Lee YC, Kim TN, Jee SR, Park SY, Kim JG, Park JJ, Kim SG, Park JM, Park JH, Park SJ, Lee OY. Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial. Medicine (Baltimore). 2023 Dec 8;102(49):e35926. doi: 10.1097/MD.0000000000035926.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A74_02AG/CG1904
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.