Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia

NCT04482478 | Recruiting

• 1 other identifier: NOVAKM_EDL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Functional Dyspepsia

Keywords

Functional Dyspepsia; GSRS

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (10)

• GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score

  6 weeks

• GSRS(Gastrointestinal Symptom Rating Scale) Total score

  6 weeks, 12 weeks

• GIS(Gastrointestinal Symptom)

  6 weeks, 12 weeks

• FD-QoL(Functional Dyspepsia-Related Quality of Life)

  12 weeks

• ESR(Erythrocyte Sedimentation Rate)

  6 weeks, 12 weeks

Study Arms (2)

EDL(Extract of Dolichos lablab Linne)

EXPERIMENTAL

The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks.

Dietary Supplement: Extract of Dolichos lablab Linne (EDL)

Placebo comparator

PLACEBO COMPARATOR

The randomly assigned target was given a placebo for 12 weeks.

Other: Placebo oral tablet

Interventions

Extract of Dolichos lablab Linne (EDL) DIETARY_SUPPLEMENT

Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)

EDL(Extract of Dolichos lablab Linne)

Placebo oral tablet OTHER

Placebo: consumed in the same way as the investigational product

Placebo comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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}
• 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.
• 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)
• Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL)
• Those whose Creatinine is more than twice the normal upper limit of the study institution
• Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution
• Persons who are sensitive or allergic to investigational product for this clinical trial
• Pregnant, lactating or planning to become pregnant within 3 months
• 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.
• A person who determines that the Investigator is inappropriate for clinical trials

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Study Officials

• Nayoung Kim, M.D., Ph. D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayoung Kim, M.D., Ph. D.

CONTACT

82-31-787-7008; nayoung49@empas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational product or placebo for 12 weeks. Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day) Placebo: consumed in the same way as the investigational product

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2020
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

KR (1)