<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482478</url>
  </required_header>
  <id_info>
    <org_study_id>NOVAKM_EDL</org_study_id>
    <nct_id>NCT04482478</nct_id>
  </id_info>
  <brief_title>Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia</brief_title>
  <official_title>A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial was designed to evaluate the functional and safety effects on dyspeptic&#xD;
      symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in&#xD;
      adults who complain of dyspeptic symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dyspepsia is a common disease and accounts for about 5% of all patients visiting primary&#xD;
      care. Of these, about 70~90% of dyspeptic patients who visit the tertiary medical institution&#xD;
      have functional digestion, considering that about 8~20% of dyspeptic patients who are&#xD;
      referred from the primary medical institution to the tertiary medical institution are found.&#xD;
      It is estimated to be bad. Functional dyspepsia is not life-threatening, but its symptoms&#xD;
      persist throughout life and are not easily cured, which can limit social life and reduce the&#xD;
      quality of life.&#xD;
&#xD;
      Therefore, this clinical trial was designed to evaluate the functional and safety effects on&#xD;
      dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab&#xD;
      Linne) in adults who complain of dyspeptic symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.&#xD;
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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score</measure>
    <time_frame>12 weeks</time_frame>
    <description>GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 12 weeks of administration, compared to Baseline.&#xD;
the unabbreviated scale title: Gastrointestinal Symptom Rating Scale&#xD;
the minimum and maximum values: 0, 24&#xD;
higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score</measure>
    <time_frame>6 weeks</time_frame>
    <description>GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 6 weeks of administration, compared to Baseline.&#xD;
the unabbreviated scale title: Gastrointestinal Symptom Rating Scale&#xD;
the minimum and maximum values: 0, 24&#xD;
higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GSRS(Gastrointestinal Symptom Rating Scale) Total score</measure>
    <time_frame>6 weeks, 12 weeks</time_frame>
    <description>GSRS (Gastrointestinal Symptom Rating Scale) Total score change after 6 weeks, 12 weeks of administration, compared to Baseline.&#xD;
the unabbreviated scale title: Gastrointestinal Symptom Rating Scale&#xD;
the minimum and maximum values: 0, 45&#xD;
higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GIS(Gastrointestinal Symptom)</measure>
    <time_frame>6 weeks, 12 weeks</time_frame>
    <description>GIS(Gastrointestinal Symptom) score change after 6 weeks, 12 weeks of administration, compared to Baseline.&#xD;
the unabbreviated scale title: Gastrointestinal Symptom&#xD;
the minimum and maximum values: 0, 40&#xD;
higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FD-QoL(Functional Dyspepsia-Related Quality of Life)</measure>
    <time_frame>12 weeks</time_frame>
    <description>FD-QoL(Functional Dyspepsia-Related Quality of Life) score change after 12 weeks of administration, compared to Baseline.&#xD;
the unabbreviated scale title: Functional Dyspepsia-Related Quality of Life&#xD;
the minimum and maximum values: 0, 84&#xD;
higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESR(Erythrocyte Sedimentation Rate)</measure>
    <time_frame>6 weeks, 12 weeks</time_frame>
    <description>ESR(Erythrocyte Sedimentation Rate) change after 6 weeks, 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP(C-Reactive Protein)</measure>
    <time_frame>6 weeks, 12 weeks</time_frame>
    <description>CRP(C-Reactive Protein) change after 6 weeks, 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IFN-γ(Interferon)</measure>
    <time_frame>12 weeks</time_frame>
    <description>IFN-γ(Interferon) change after 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α(Tumor necrosis factors)</measure>
    <time_frame>12 weeks</time_frame>
    <description>TNF-α(Tumor necrosis factors) change after 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-OhdG(8-Oxo-2'-deoxyguanosine)</measure>
    <time_frame>12 weeks</time_frame>
    <description>8-OhdG(8-Oxo-2'-deoxyguanosine) change after 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TAS(total antioxidnat status)</measure>
    <time_frame>12 weeks</time_frame>
    <description>TAS(total antioxidnat status) change after 12 weeks of administration, compared to Baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>EDL(Extract of Dolichos lablab Linne)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The randomly assigned target was given a placebo for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Extract of Dolichos lablab Linne (EDL)</intervention_name>
    <description>Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)</description>
    <arm_group_label>EDL(Extract of Dolichos lablab Linne)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo oral tablet</intervention_name>
    <description>Placebo: consumed in the same way as the investigational product</description>
    <arm_group_label>Placebo comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Those over the age of 19&#xD;
&#xD;
          2. Those diagnosed with functional dyspepsia (Rome IV*)&#xD;
&#xD;
             * One or more of the following symptoms are diagnosed when there is no organic cause&#xD;
             in the test including the upper gastrointestinal endoscopy(if symptoms begin 6 months&#xD;
             prior to Visit 1, and the symptoms are present in the past 3 months).&#xD;
&#xD;
               -  Othersome postprandial fullness&#xD;
&#xD;
               -  Unpleasant early satiation&#xD;
&#xD;
               -  Unpleasant epigastric pain&#xD;
&#xD;
               -  Unpleasant epigastric burning&#xD;
&#xD;
          3. A person who has 4 or more of the 10 symptoms in the GIS (Gastrointestinal Symptom)&#xD;
             questionnaire and has a total score of 12 or more (5-point Likert scale)&#xD;
&#xD;
          4. When there is no organic disease in the gastroscopy performed at Visit 1 (however, it&#xD;
             can be replaced by the test results within 3 months from Visit 1)&#xD;
&#xD;
          5. A person who consented to participate in this clinical trial and signed a Informed&#xD;
             consent form before the trail began.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Persons who are currently being treated with severe cardiovascular system, immune&#xD;
             system, respiratory system, hepatobiliary system, kidney and urinary system, nervous&#xD;
             system, musculoskeletal system, mental, infectious diseases, and malignant tumors&#xD;
             (however, considering the condition of the subjects, subjects can participate in the&#xD;
             test according to investigator's judgment.)&#xD;
&#xD;
          2. Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit&#xD;
             1&#xD;
&#xD;
          3. Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)&#xD;
&#xD;
          4. Persons with a history of malignancy of the digestive system&#xD;
&#xD;
          5. Those who have taken H2 receptor blockers, anticholinergic agents (muscarinic receptor&#xD;
             antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump&#xD;
             inhibitors, gastric mucosal protective agents, other drugs intended to treat&#xD;
             gastritis, gastric health-related health functional food within 2 weeks of Visit 1&#xD;
&#xD;
          6. Those who need to constantly take medications that can cause gastritis, such as&#xD;
             adrenal cortical hormones, nonsteroidal anti-inflammatory drugs, and aspirin during&#xD;
             the human application test {However, low-dose aspirin for cardiovascular disease&#xD;
             prevention (100 mg/day or less) permit}&#xD;
&#xD;
          7. In the Drinking Habit Questionnaire, those who had an average alcohol intake of 14&#xD;
             units or more for men and or more 7 units for women per week for the past month.&#xD;
&#xD;
          8. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or&#xD;
             diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes&#xD;
             of stability in human subjects)&#xD;
&#xD;
          9. Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL)&#xD;
&#xD;
         10. Those whose Creatinine is more than twice the normal upper limit of the study&#xD;
             institution&#xD;
&#xD;
         11. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the&#xD;
             study institution&#xD;
&#xD;
         12. Persons who are sensitive or allergic to investigational product for this clinical&#xD;
             trial&#xD;
&#xD;
         13. Pregnant, lactating or planning to become pregnant within 3 months&#xD;
&#xD;
         14. Those who participated in other clinical trials within 3 months of Visit 1 or plan to&#xD;
             participate in other clinical trials after the start of this clinical trials.&#xD;
&#xD;
         15. A person who determines that the Investigator is inappropriate for clinical trials&#xD;
&#xD;
         16. Employee of Department of Digestive Internal Medicine, Seoul National University&#xD;
             Bundang Hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nayoung Kim, M.D., Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nayoung Kim, M.D., Ph. D.</last_name>
    <phone>82-31-787-7008</phone>
    <email>nayoung49@empas.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nayoung Kim</last_name>
      <phone>82317877009</phone>
      <email>nayoungkim49@empas.com</email>
    </contact>
    <contact_backup>
      <phone>821052164932</phone>
    </contact_backup>
    <investigator>
      <last_name>Nayoung Kim, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Nayoung Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Functional Dyspepsia</keyword>
  <keyword>GSRS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482478
org study id: NOVAKM_EDL
nct id: NCT04482478
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
time frame: 12 weeks
description: 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.
measure: GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score
time frame: 6 weeks
description: 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.
measure: GSRS(Gastrointestinal Symptom Rating Scale) Total score
time frame: 6 weeks, 12 weeks
description: 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.
measure: GIS(Gastrointestinal Symptom)
time frame: 6 weeks, 12 weeks
description: 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.
measure: FD-QoL(Functional Dyspepsia-Related Quality of Life)
time frame: 12 weeks
description: 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.
measure: ESR(Erythrocyte Sedimentation Rate)
time frame: 6 weeks, 12 weeks
description: ESR(Erythrocyte Sedimentation Rate) change after 6 weeks, 12 weeks of administration, compared to Baseline.
measure: CRP(C-Reactive Protein)
time frame: 6 weeks, 12 weeks
description: CRP(C-Reactive Protein) change after 6 weeks, 12 weeks of administration, compared to Baseline.
measure: IFN-γ(Interferon)
time frame: 12 weeks
description: IFN-γ(Interferon) change after 12 weeks of administration, compared to Baseline.
measure: TNF-α(Tumor necrosis factors)
time frame: 12 weeks
description: TNF-α(Tumor necrosis factors) change after 12 weeks of administration, compared to Baseline.
measure: 8-OhdG(8-Oxo-2'-deoxyguanosine)
time frame: 12 weeks
description: 8-OhdG(8-Oxo-2'-deoxyguanosine) change after 12 weeks of administration, compared to Baseline.
measure: TAS(total antioxidnat status)
time frame: 12 weeks
description: TAS(total antioxidnat status) change after 12 weeks of administration, compared to Baseline.
arm group label: EDL(Extract of Dolichos lablab Linne)
arm group type: Experimental
description: The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks.
arm group label: Placebo comparator
arm group type: Placebo Comparator
description: The randomly assigned target was given a placebo for 12 weeks.
intervention type: Dietary Supplement
intervention name: Extract of Dolichos lablab Linne (EDL)
description: Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)
arm group label: EDL(Extract of Dolichos lablab Linne)
intervention type: Other
intervention name: Placebo oral tablet
description: Placebo: consumed in the same way as the investigational product
arm group label: Placebo comparator
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nayoung Kim, M.D., Ph. D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Nayoung Kim, M.D., Ph. D.
phone: 82-31-787-7008
email: nayoung49@empas.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Nayoung Kim
investigator title: Professor
mesh term: Dyspepsia