Functional DyspepsiaNCT04482478
Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
A study testing Extract of Dolichos lablab Linne (EDL) in people with Functional Dyspepsia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Extract of Dolichos lablab Linne (EDL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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}
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- 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
- Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Nayoung Kim, 82317877009, nayoungkim49@empas.com
821052164932
About this study
Official title: A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
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.
Read the detailed description
Dyspepsia is a common disease and accounts for about 5% of all patients visiting primary care. Of these, about 70~90% of dyspeptic patients who visit the tertiary medical institution have functional digestion, considering that about 8~20% of dyspeptic patients who are referred from the primary medical institution to the tertiary medical institution are found. It is estimated to be bad. Functional dyspepsia is not life-threatening, but its symptoms persist throughout life and are not easily cured, which can limit social life and reduce the quality of life.
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
- Functional Dyspepsia
- Being tested
- Extract of Dolichos lablab Linne (EDL), Placebo oral tablet
- Keywords
- Functional Dyspepsia, GSRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Placebo oral tabletOther
Placebo: consumed in the same way as the investigational product
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Extract of Dolichos lablab Linne (EDL) |
| Placebo comparator | Placebo comparator | The randomly assigned target was given a placebo for 12 weeks. Receives: Other: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (10)
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 6 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.
Measured: 6 weeks
GSRS(Gastrointestinal Symptom Rating Scale) Total score
GSRS (Gastrointestinal Symptom Rating Scale) Total score change after 6 weeks, 12 weeks of administration, compared to Baseline.
- the unabbreviated scale title: Gastrointestinal Symptom Rating Scale
- the minimum and maximum values: 0, 45
- higher scores mean a worse outcome.
Measured: 6 weeks, 12 weeks
GIS(Gastrointestinal Symptom)
GIS(Gastrointestinal Symptom) score change after 6 weeks, 12 weeks of administration, compared to Baseline.
- the unabbreviated scale title: Gastrointestinal Symptom
- the minimum and maximum values: 0, 40
- higher scores mean a worse outcome.
Measured: 6 weeks, 12 weeks
FD-QoL(Functional Dyspepsia-Related Quality of Life)
FD-QoL(Functional Dyspepsia-Related Quality of Life) score change after 12 weeks of administration, compared to Baseline.
- the unabbreviated scale title: Functional Dyspepsia-Related Quality of Life
- the minimum and maximum values: 0, 84
- higher scores mean a worse outcome.
Measured: 12 weeks
ESR(Erythrocyte Sedimentation Rate)
ESR(Erythrocyte Sedimentation Rate) change after 6 weeks, 12 weeks of administration, compared to Baseline.
Measured: 6 weeks, 12 weeks
CRP(C-Reactive Protein)
CRP(C-Reactive Protein) change after 6 weeks, 12 weeks of administration, compared to Baseline.
Measured: 6 weeks, 12 weeks
IFN-γ(Interferon)
IFN-γ(Interferon) change after 12 weeks of administration, compared to Baseline.
Measured: 12 weeks
TNF-α(Tumor necrosis factors)
TNF-α(Tumor necrosis factors) change after 12 weeks of administration, compared to Baseline.
Measured: 12 weeks
8-OhdG(8-Oxo-2'-deoxyguanosine)
8-OhdG(8-Oxo-2'-deoxyguanosine) change after 12 weeks of administration, compared to Baseline.
Measured: 12 weeks
TAS(total antioxidnat status)
TAS(total antioxidnat status) change after 12 weeks of administration, compared to Baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph. D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482478
- Sponsor's protocol ID
- NOVAKM_EDL
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
- ClinicalTrials.gov ID
- NCT04482478
- Acronym / sponsor ID
- NOVAKM_EDL
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, GSRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dyspepsia is a common disease and accounts for about 5% of all patients visiting primary care. Of these, about 70~90% of dyspeptic patients who visit the tertiary medical institution have functional digestion, considering that about 8~20% of dyspeptic patients who are referred from the primary medical institution to the tertiary medical institution are found. It is estimated to be bad. Functional dyspepsia is not life-threatening, but its symptoms persist throughout life and are not easily cured, which can limit social life and reduce the quality of life.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| EDL(Extract of Dolichos lablab Linne) | Experimental | Dietary Supplement: Extract of Dolichos lablab Linne (EDL)The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks. |
| Placebo comparator | Placebo comparator | Other: Placebo oral tabletThe randomly assigned target was given a placebo for 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Those over the age of 19
- Those diagnosed with functional dyspepsia (Rome IV*)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extract of Dolichos lablab Linne (EDL)Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day) | Dietary supplement | EDL(Extract of Dolichos lablab Linne) |
| Placebo oral tabletPlacebo: consumed in the same way as the investigational product | Other | Placebo comparator |
Primary outcome
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
Time frame: 12 weeks
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.
10 secondary outcomes
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
Time frame: 6 weeks
GSRS(Gastrointestinal Symptom Rating Scale) Total score
Time frame: 6 weeks, 12 weeks
GIS(Gastrointestinal Symptom)
Time frame: 6 weeks, 12 weeks
FD-QoL(Functional Dyspepsia-Related Quality of Life)
Time frame: 12 weeks
ESR(Erythrocyte Sedimentation Rate)
Time frame: 6 weeks, 12 weeks
CRP(C-Reactive Protein)
Time frame: 6 weeks, 12 weeks
IFN-γ(Interferon)
Time frame: 12 weeks
TNF-α(Tumor necrosis factors)
Time frame: 12 weeks
8-OhdG(8-Oxo-2'-deoxyguanosine)
Time frame: 12 weeks
TAS(total antioxidnat status)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nayoung Kim, M.D., Ph. D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extract of Dolichos lablab Linne (EDL) in people with Functional Dyspepsia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nayoung Kim, M.D., Ph. D. (82-31-787-7008, nayoung49@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.