Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
NCT ID: NCT04482478
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-07-01
2025-12-30
Brief Summary
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Detailed Description
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Therefore, 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
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
QUADRUPLE
Study Groups
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EDL(Extract of Dolichos lablab Linne)
The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks.
Extract of Dolichos lablab Linne (EDL)
Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)
Placebo comparator
The randomly assigned target was given a placebo for 12 weeks.
Placebo oral tablet
Placebo: consumed in the same way as the investigational product
Interventions
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Extract of Dolichos lablab Linne (EDL)
Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)
Placebo oral tablet
Placebo: consumed in the same way as the investigational product
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Nayoung Kim
Professor
Principal Investigators
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Nayoung Kim, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Nayoung Kim, M.D.,Ph.D.
Role: backup
Other Identifiers
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NOVAKM_EDL
Identifier Type: -
Identifier Source: org_study_id