Actively Recruiting
Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
Led by Seoul National University Bundang Hospital · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Diagnosed with functional dyspepsia according to Rome IV criteria
- Presence of one or more symptoms such as postprandial fullness, early satiation, epigastric pain, or burning without organic cause
- Having at least 4 of 10 symptoms on the Gastrointestinal Symptom questionnaire with a total score of 12 or higher
- No organic disease found on gastroscopy performed at Visit 1 or within 3 months prior
- Provided signed informed consent to participate in the trial
You will not qualify if you...
- Currently treated for severe diseases of cardiovascular, immune, respiratory, liver, kidney, nervous, musculoskeletal, mental, infectious diseases, or cancer unless investigator allows
- History of peptic ulcer or reflux esophagitis within 6 months before Visit 1
- History of gastrointestinal surgery except appendectomy or hemorrhoidectomy
- History of digestive system malignancy
- Use of certain gastrointestinal medications or related health foods within 2 weeks of Visit 1
- Need for ongoing medications causing gastritis except low-dose aspirin (100 mg/day or less)
- Alcohol intake averaging 14 or more units per week for men, or 7 or more for women in past month
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg after rest)
- Uncontrolled diabetes (fasting blood sugar over 180 mg/dL)
- Creatinine level more than twice the normal upper limit
- AST(GOT) or ALT(GPT) more than 3 times the normal upper limit
- Allergy or sensitivity to the investigational product
- Pregnant, breastfeeding, or planning pregnancy within 3 months
- Participation in other clinical trials within 3 months before or planned during this trial
- Deemed inappropriate for the trial by the investigator
- Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
N
Nayoung Kim, M.D., Ph. D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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