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*)
Othersome postprandial fullness
Unpleasant early satiation
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
Parallel
Extract of Dolichos lablab Linne (EDL)
Dietary supplementInvestigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)
Placebo oral tablet
Other interventionPlacebo: consumed in the same way as the investigational product
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 12 weeks of administration, compared to Baseline. * the unabbreviated scale title: Gastrointestinal Symptom Rating Scale * the minimum and maximum values: 0, 24 * higher scores mean a worse outcome.
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 6 weeks of administration, compared to Baseline. * the unabbreviated scale title: Gastrointestinal Symptom Rating Scale * the minimum and maximum values: 0, 24 * higher scores mean a worse outcome.
GSRS(Gastrointestinal Symptom Rating Scale) Total score
GSRS (Gastrointestinal Symptom Rating Scale) Total score change after 6 weeks, 12 weeks of administration, compared to Baseline. * the unabbreviated scale title: Gastrointestinal Symptom Rating Scale * the minimum and maximum values: 0, 45 * higher scores mean a worse outcome.
GIS(Gastrointestinal Symptom)
GIS(Gastrointestinal Symptom) score change after 6 weeks, 12 weeks of administration, compared to Baseline. * the unabbreviated scale title: Gastrointestinal Symptom * the minimum and maximum values: 0, 40 * higher scores mean a worse outcome.
FD-QoL(Functional Dyspepsia-Related Quality of Life)
FD-QoL(Functional Dyspepsia-Related Quality of Life) score change after 12 weeks of administration, compared to Baseline. * the unabbreviated scale title: Functional Dyspepsia-Related Quality of Life * the minimum and maximum values: 0, 84 * higher scores mean a worse outcome.
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