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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Extract of Dolichos lablab Linne (EDL)
* Other: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDL(Extract of Dolichos lablab Linne)<br>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)<br>* Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)<br>|
| Placebo Comparator: Placebo comparator<br>The randomly assigned target was given a placebo for 12 weeks. | Other: Placebo oral tablet<br>* Placebo: consumed in the same way as the investigational product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 12 weeks | 
| ESR(Erythrocyte Sedimentation Rate) | ESR(Erythrocyte Sedimentation Rate) change after 6 weeks, 12 weeks of administration, compared to Baseline. | 6 weeks, 12 weeks | 
| CRP(C-Reactive Protein) | CRP(C-Reactive Protein) change after 6 weeks, 12 weeks of administration, compared to Baseline. | 6 weeks, 12 weeks | 
| IFN-γ(Interferon) | IFN-γ(Interferon) change after 12 weeks of administration, compared to Baseline. | 12 weeks | 
| TNF-α(Tumor necrosis factors) | TNF-α(Tumor necrosis factors) change after 12 weeks of administration, compared to Baseline. | 12 weeks | 
| 8-OhdG(8-Oxo-2'-deoxyguanosine) | 8-OhdG(8-Oxo-2'-deoxyguanosine) change after 12 weeks of administration, compared to Baseline. | 12 weeks | 
| TAS(total antioxidnat status) | TAS(total antioxidnat status) change after 12 weeks of administration, compared to Baseline. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, GSRS