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
CRIS Registration Number |
KCT0005439 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Daejeon Korean Medicine Hospital of Daejeon University |
Organization Type | Medical Institute |
Project ID | DJDSKH-20-BM-06 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daejeon Korean Medicine Hospital of Daejeon University |
Organization Type | Medical Institute |
7. Study Summary
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) |
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8. Study Design
Study Type | Observational Study |
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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
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. |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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