Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
Healthy Volunteers
NCT04482478

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

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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