Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia (NCT04482478) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
South Korea100 participantsStarted 2020-07-01
Plain-language summary
This clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Those over the age of 19
✓. Those diagnosed with functional dyspepsia (Rome IV\*)
✓. 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)
✓. 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)
✓. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
Exclusion criteria
✕. 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.)
✕. Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit 1
✕. Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)
✕. Persons with a history of malignancy of the digestive system
✕. 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
✕. 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}
✕. 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.
✕. 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)