Evaluating the effects of EDL on dyspepsia symptoms

A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia

This study is testing whether a natural extract called EDL can help adults with functional dyspepsia feel better compared to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Bundang Hospital (other)
• Locations: 1 site (Seongnam-si, Gyeonggi-do)
• Trial ID: NCT04482478 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of Extract of Dolichos lablab Linne (EDL) in alleviating symptoms of functional dyspepsia compared to a placebo. Functional dyspepsia is a prevalent condition that significantly impacts patients' quality of life, and this trial seeks to provide a potential treatment option. Participants will be adults diagnosed with functional dyspepsia who will receive either EDL or a placebo in a controlled setting. The study will measure changes in dyspeptic symptoms using standardized questionnaires and clinical evaluations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over the age of 19 diagnosed with functional dyspepsia and experiencing specific gastrointestinal symptoms.

Not a fit: Patients with organic gastrointestinal diseases or those currently undergoing treatment for severe dyspeptic symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could offer a new treatment option for patients suffering from functional dyspepsia, improving their quality of life.

How similar studies have performed: While there have been studies on various treatments for dyspepsia, the specific use of EDL is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Those over the age of 19
2. 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
3. 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)
4. 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)
5. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.

Exclusion Criteria:

1. 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.)
2. Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit 1
3. Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)
4. Persons with a history of malignancy of the digestive system
5. Those who have taken H2 receptor blockers, anticholinergic agents (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health-related health functional food within 2 weeks of Visit 1
6. Those who need to constantly take medications that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti-inflammatory drugs, and aspirin during the human application test {However, low-dose aspirin for cardiovascular disease prevention (100 mg/day or less) permit}
7. In the Drinking Habit Questionnaire, those who had an average alcohol intake of 14 units or more for men and or more 7 units for women per week for the past month.
8. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)
9. Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL)
10. Those whose Creatinine is more than twice the normal upper limit of the study institution
11. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution
12. Persons who are sensitive or allergic to investigational product for this clinical trial
13. Pregnant, lactating or planning to become pregnant within 3 months
14. Those who participated in other clinical trials within 3 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trials.
15. A person who determines that the Investigator is inappropriate for clinical trials
16. Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital

Where this trial is running

Seongnam-si, Gyeonggi-do

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)

Study contacts

• Principal investigator: Nayoung Kim, M.D., Ph. D. — Seoul National University Bundang Hospital
• Study coordinator: Nayoung Kim, M.D., Ph. D.

Conditions: Functional Dyspepsia, GSRS