Efficacy and safety study of WSY-S
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003761
- Lead Sponsor
- Kyung Hee University Hosipital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Men and women over 20 years old and under 70 years old
2) Those diagnosed with functional dyspepsia (Rome IV *)
1) Patients with a history of severe malignancy, cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment) within the past 6 months. (In the case of a stable subject, the examiner can include those subjects by judgment.)
2) Those with a history of peptic ulcer and reflux esophagitis within 6 months
3) Patients who had previous gastric acid suppression surgery or gastroesophageal surgery
4) Patients with a history of gastrointestinal malignancies
5) Within 2 weeks of the start of the study, a combination of an H2 receptor blocker, an anticholinergic agent (muscarinic receptor antagonist), a gastrin receptor antagonist, a prostaglandin agent, a proton pump inhibitor, a gastric mucosal protective agent
6) Persons who are to continue taking medications that may cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin
7) Drinker: for men who consumed more than 14 units of alcohol per week and for women who consumed more than 7 units of alcohol per week during the past month
8) Patients with uncontrolled hypertension (over 160 / 100mmHg, measured after 10 minutes of test subjects)
9) Unregulated diabetic patients (fasting blood sugar 180 mg/dl or more)
10) Creatinine is at least twice the normal upper normal limit
11) AST/ALT is at least three times the normal upper limit of the test laboratory.
12) Patients with uncontrolled thyroid disease
13) Those planning to become pregnant within 3 months, during pregnancy or lactation
14) Those who have participated in another human application test within one month, or are planning to participate in another human application test during this human application period
15) Any person deemed inappropriate for this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastrointestinal Symptom Rating Scale (GSRS)
- Secondary Outcome Measures
Name Time Method epean dyspepsia index-Korean version, World Health Organization Quality of Life Assessment Instrument