A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
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.
• Those over the age of 19
• 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
• 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.