KCT0005229
Recruiting
未知
A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
ovaKmed0 sites100 target enrollmentTBD
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- ovaKmed
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Those over the age of 19
- •2\) Those diagnosed with functional dyspepsia (Rome IV\*)
- •\* One or more of the following symptoms are diagnosed when there is no organic cause in the test including the upper gastrointestinal endoscopy(if symptoms begin 6 months prior to Visit 1, and the symptoms are present in the past 3 months).
- •\- Othersome postprandial fullness
- •\- Unpleasant early satiation
- •\- Unpleasant epigastric pain
- •\-Unpleasant epigastric burning
- •3\) A person who has 4 or more of the 10 symptoms in the GIS (Gastrointestinal Symptom) questionnaire and has a total score of 12 or more (5\-point Likert scale)
- •4\) When there is no organic disease in the gastroscopy performed at Visit 1 (however, it can be replaced by the test results within 3 months from Visit 1\)
- •5\) A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
Exclusion Criteria
- •1\) Persons who are currently being treated with severe cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors (however, considering the condition of the subjects, subjects can participate in the test according to investigator's judgment.)
- •2\) Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit 1
- •3\) Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)
- •4\) Persons with a history of malignancy of the digestive system
- •5\) Those who have taken H2 receptor blockers, anticholinergic agents (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health\-related health functional food within 2 weeks of Visit 1
- •6\) Those who need to constantly take medications that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti\-inflammatory drugs, and aspirin during the human application test {However, low\-dose aspirin for cardiovascular disease prevention (100 mg/day or less) permit}
- •7\) In the Drinking Habit Questionnaire, those who had an average alcohol intake of 14 units or more for men and or more 7 units for women per week for the past month.
- •8\) Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)
- •9\) Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL)
- •10\) Those whose Creatinine is more than twice the normal upper limit of the study institution
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Placebo-Controlled Clinical Trial of Efficacy and Safety of MC01 on the Skin Wrinkle Improvement and MoisturizingDiseases of the skin and subcutaneous tissueKCT0007499Maeil Health Nutrition100
Completed
Not Applicable
A 12 Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of NVP-2106 on improvement of Cognitive FunctioKCT0009187VP Healthcare120
Active, not recruiting
Not Applicable
Clinical Trial for the Evaluation of the Efficacy and Safety of L. curvatus HY7601 and L. plantarum KY1032 on Reducing body weight and body fat on Overweight or Obesity subjectsEndocrine, nutritional and metabolic diseasesKCT0007117Vievis NAMUH Hospital72
Active, not recruiting
Not Applicable
The Efficacy and Safety of MKC on the Skin Wrinkle Improvement and MoisturizingKCT0006416Holistic Bio100
Completed
Not Applicable
A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactobacillus plantarum LMT1-48 on Reducing Body FatEndocrine, nutritional and metabolic diseasesKCT0008055Global Medical Research Center120