The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.
GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
Administer 25mg of GC6101A t.i.d for 2 weeks.
Administer 50mg of GC6101A t.i.d for 2 weeks.
Inje University, Busan Paik Hospital of Korea
Busan, South Korea
RECRUITINGKeimyung University, Dongsan Medical Center of Korea
Daegu, South Korea
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
Time frame: 2 weeks
A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
The definition of "significant improvement" is the subject showed score changed from 2-4 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
Time frame: 2 weeks
A percentage of subjects showed improvement of edema rating scale
The definition of "improvement" is the subjects showed score changed from 2 to 1.
Time frame: 2 weeks
A percentage of subjects showed improvement of erythema rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time frame: 2 weeks
A percentage of subjects showed improvement of hemorrhage rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time frame: 2 weeks
A percentage of subjects showed improvement of gastric symptom rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Time frame: 2 weeks
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Administer placebo t.i.d for 2 weeks
Wonkwang University, Hospital of Korea
Iksan-si, South Korea
RECRUITINGSeoul National University, Bundang Hospital of Korea
Seongnam-si, South Korea
RECRUITINGChungang University, Hospital of Korea
Seoul, South Korea
RECRUITINGEwha Womans University, Medical Center of Korea
Seoul, South Korea
RECRUITINGInje University, Seoul Paik Hospital of Korea
Seoul, South Korea
RECRUITINGKankbuk Samsung Medical Center of Korea
Seoul, South Korea
RECRUITINGKorea University, Guro Hospital of Korea
Seoul, South Korea
RECRUITINGSeoul National University, Hospital of Korea
Seoul, South Korea
RECRUITING...and 4 more locations
Adverse Events
Time frame: 2 weeks
Lab results(Hematology, Blood chemistry, Urinalysis)
Time frame: 2 weeks
The results of physical examinations and Vital signs(body temperature, pulse)
Time frame: 2 weeks
EKG results
Time frame: 2 weeks