Actively Recruiting
A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Effects of Extract of Dolichos lablab Linne on Functional Dyspepsia
Led by Seoul National University Bundang Hospital · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of Extract of Dolichos lablab Linne (EDL) on adults who experience functional dyspepsia, a common digestive disorder that can cause persistent discomfort and lower quality of life. The study aims to compare the functional and safety effects of EDL against a placebo in relieving dyspeptic symptoms. This trial is randomized, double-blind, and placebo-controlled, focusing on adults diagnosed with functional dyspepsia according to specific diagnostic criteria. Participants are randomly assigned to receive either 715 mg per day of EDL or a placebo for 12 weeks. The investigational product is taken orally once daily as two tablets. The study monitors symptoms and safety outcomes throughout the 12-week treatment period to assess the impact of EDL compared to placebo. During the study, participants will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) for stomach symptoms at 6 and 12 weeks, along with other assessments such as the Gastrointestinal Symptom questionnaire, Functional Dyspepsia-Related Quality of Life, and various blood markers. The research team also tracks inflammatory and antioxidant markers to understand safety and physiological effects. Overall participation includes initial screening, 12 weeks of treatment, and regular symptom and safety assessments.
CONDITIONS
Brief 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...
- Adults aged 19 years or older
- Diagnosed with functional dyspepsia according to Rome IV criteria
- Experience one or more symptoms such as postprandial fullness, early satiation, epigastric pain, or epigastric burning for at least 3 months
- Have 4 or more symptoms on the Gastrointestinal Symptom questionnaire with a total score of 12 or more
- No organic disease found by gastroscopy within 3 months of study start
- Provided informed consent before beginning the trial
You will not qualify if you...
- Currently treated for severe cardiovascular, immune, respiratory, liver, kidney, nervous, musculoskeletal, mental, infectious diseases, or cancer (subject to investigator judgment)
- History of peptic ulcer or reflux esophagitis within 6 months before study start
- Previous gastrointestinal surgery except appendectomy or hemorrhoidectomy
- History of digestive system cancer
- Use of certain gastric medications or functional foods within 2 weeks before study start
- Need for ongoing medication that may cause gastritis, except low-dose aspirin (100 mg/day or less)
- High average alcohol intake (14 or more units/week for men, 7 or more units/week for women) in the past month
- Uncontrolled hypertension or diabetes
- Elevated creatinine, AST, or ALT levels beyond study limits
- Allergic or sensitive 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
- Judged unsuitable for trial by the investigator
- Employee of the Department of Digestive Internal Medicine at the sponsoring hospital
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either Extract of Dolichos lablab Linne (EDL) or a placebo daily to evaluate effects on functional dyspepsia symptoms.
Baseline visit and follow-up visits at 6 weeks and 12 weeks
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.
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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