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An Observational Study on Effect of Herbal Medicine Treatment and Change of Gut Microbiome in Functional Dyspepsia Patients

Status Approved

  • First Submitted Date

    2020/07/06

  • Registered Date

    2020/09/25

  • Last Updated Date

    2020/07/06

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005439
    Unique Protocol ID DJNM_20_01
    Public/Brief Title An Observational Study on Effect of Herbal Medicine Treatment and Change of Gut Microbiome in Functional Dyspepsia Patients
    Scientific Title An Observational Study on Effect of Herbal Medicine Treatment and Change of Gut Microbiome in Functional Dyspepsia Patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DJDSKH-20-BM-06
    Approval Date 2020-06-05
    Institutional Review Board Name Daejeon University Dunsan Korean Medicine Hospital Institutional Review Board
    Institutional Review Board Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-470-9488
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Chung sik Cho
    Title Professor
    Telephone +82-42-470-9135
    Affiliation Daejeon Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Contact Person for Public Queries
    Name Cheon hoo Jeon
    Title Resident
    Telephone +82-42-470-9135
    Affiliation Daejeon Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Contact Person for Updating Information
    Name Hae sook Kim
    Title CRC
    Telephone +82-42-470-9494
    Affiliation Daejeon Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-06-05 Actual
    Target Number of Participant 10
    Primary Completion Date 2020-08-31 , Anticipated
    Study Completion Date 2020-09-18 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-05 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Daejeon Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
    Project ID DJDSKH-20-BM-06
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daejeon Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This is a non-control prospective observational study of patients with dyspepsia who visit a hospital, to check the types and effects of herbal medicines used in patients with categorized of "phlegm-fluid retention", evaluate the usefulness of the evaluation tool, and change intestinal microflora for 2 weeks Observe.
    
    The purpose of this clinical study was to investigate clinical observation information in patients with functional dyspepsia between the ages of 19 to 65.
    If the research subject agrees in writing to participate in the clinical research in person, the clinical case information will be collected after confirming whether the research target is suitable for the selection criteria and exclusion criteria.
    
    [Primary effectiveness evaluation]
    1. Intestinal microflora: The rate of change in the proportion of microorganisms by evaluation point (after 0, 1 week)
    
    [Secondary effectiveness evaluation]
    1.NDI-K: Score change amount by evaluation point (after 0, 2 weeks)
    2.NDI-K quality of life: score change by evaluation point (after 0, 2 weeks)
    3.phlegm-fluid retention pattern questionnaire: Amount of change in score by evaluation point (after Screening, after 1 or 2 weeks)
    4.VAS: The amount of change in score by evaluation point (after 0, 1, 2 weeks)
    5.BMI: The amount of change in score by evaluation point (after 0, 1, 2 weeks)
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 10
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    The patients with functional dyspepsia diagnosis with categorized of "Dam-Eum"

    Cohort/Group Description

    An Observational Study on Effect of Herbal Medicine Treatment and Change of Gut Microbiome in Functional Dyspepsia Patients with Categorized of "phlegm-fluid retention"
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description
    stool
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    In order to treat functional dyspepsia at the Daejeon Oriental Medical Hospital of Daejeon University, consent is obtained and the study is conducted if the patient meets the criteria.
    Sampling Method
    Rome Ⅳ Criteria, phlegm-fluid retention pattern questionnaire , laboratory test
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K30)Functional dyspepsia 

    Functional Dyspepsia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~25Year

    Description

    1. Age from 19 yrs to 65 yrs of man or woman
    2. Subjects who have normal opinion in endoscopy within 2 years
    3. Subjects who meet the definition of ROME Ⅳ criteria
    4. Subjects who are categorized with "phlegm-fluid retention" pattern functional dyspepsia using instrument of pattern questionnaire for "phlegm-fluid retention"
    5. Subjects who give voluntarily an written consent for the trial
    Exclusion Criteria
    1. Subjects who have histories of gastrointestinal surgery (except appendectomy)
    2. Subjects who have gastrointestinal bleeding, intestinal obstruction, gastrointestinal perforation
    3. Subjects who have gastroduodenal ulcer, gastric cancer, colorectal cancer current or prior within 2 years
    4. Subjects who is undergoing treatment for eradication of H.pylori
    5. Subjects who have liver tumor, liver cirrhosis, chronic renal failure, congestive heart failure
    6. High serum AST, ALT(> 2-fold of UNL) or high serum creatinine(≥ 2.0mg/dL)
    7. Subjects who are in period of pregnancy or lactation, or planning to have a baby
    8. Subjects who drink more than three times a week or often drink excessively.
    9. Subjects who are mentally unhelthy to follow the protocol properly
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Intestinal microflora: Changes in the ratio of microorganisms by evaluation point
    Timepoint
    Base line week, 1 weeks later
    Secondary Outcome(s) 1
    Outcome
    Score change for Questionnair of NDI-K
    Timepoint
    Base line week, 2 weeks later
    Secondary Outcome(s) 2
    Outcome
    Score change for Questionnair of NDI-K quality of life
    Timepoint
    Base line day, 2 weeks
    Secondary Outcome(s) 3
    Outcome
    Score change for Questionnaire of "phelgm-fluid retention"
    Timepoint
    Screening day, 1 week, 2 weeks later
    Secondary Outcome(s) 4
    Outcome
    Score change for VAS
    Timepoint
    Base line day, 1 week, 2 weeks
    Secondary Outcome(s) 5
    Outcome
    Score change for BMI
    Timepoint
    Base line day, 1 week, 2 weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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