Gastritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Administer placebo t.i.d for 2 weeks
DRUGGC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
DRUGGC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
DRUGGC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.
Sponsors
C&R Research, Inc.
CRScube
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age is over 19 years old, men or women * Patients diagnosed with acute or chronic gastritis by gastroscopy * Patients with one or more erosions found by gastroscopy * Signed the informed consent forms
Exclusion criteria
* Patients who is impossible to receive gastroscopy * Patients with peptic ulcer and gastroesophageal reflux disease * Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy) * Patients with esophageal varix * Patients with malignant neoplasm of gastrointestinal tract * Patients with thrombosis or administered with anti-thrombotic drugs * Patients with consumption coagulopathy * Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks * Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment * Allergic or hypersensitive to any of the ingredients in the test products * Pregnant or lactating female * Patients who have abnormal baseline laboratory test result * Patients taking other investigational drugs within 30 days prior to the study. * Patients with Zollinger-Ellison syndrome * Patients that investigators consider ineligible for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy | 2 weeks | The definition of moderate improvement is the subjects showed score changed from 2-4 to 1 or from 4 to 2. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A percentage of subjects showed improvement of edema rating scale | 2 weeks | The definition of improvement is the subjects showed score changed from 2 to 1. |
| A percentage of subjects showed improvement of erythema rating scale | 2 weeks | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. |
| A percentage of subjects showed improvement of hemorrhage rating scale | 2 weeks | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. |
| A percentage of subjects showed improvement of gastric symptom rating scale | 2 weeks | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. |
| A percentage of subjects showed significant improvement of stomach erosions by the endoscopy | 2 weeks | The definition of significant improvement is the subject showed score changed from 2-4 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\] |
| Lab results(Hematology, Blood chemistry, Urinalysis) | 2 weeks | — |
| The results of physical examinations and Vital signs(body temperature, pulse) | 2 weeks | — |
| EKG results | 2 weeks | — |
| Adverse Events | 2 weeks | — |
Countries
South Korea
Contacts
Primary ContactDong-Min Kim, B.S.
Outcome results
None listed