An Observational Study on Effect of Herbal Medicine Treatment and Change of Gut Microbiome in Functional Dyspepsia Patients
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005439
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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 ? 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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal microflora: Changes in the ratio of microorganisms by <br>evaluation point
- Secondary Outcome Measures
Name Time Method Score change for Questionnair of NDI-K;Score change for Questionnair of NDI-K quality of <br>life;Score change for Questionnaire of phelgm-fluid <br>retention;Score change for VAS;Score change for BMI