Observational study on the tongue image change of functional dyspepsia patients treated by Korean herbal medicine
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002114
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1) Age between 20 and 70 years
2) Meeting the definition of functional dyspepsia according to the Rome ? criteria
3) Functional dyspepsia symptoms over the last 6 months
4) Over 43.18 value by Buzhong Yiqi Tang questionnaire score
5) Patient who have no problem communication
6) Provide consent to participate in this study and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical study
1) Individuals who have serious diseases: diseases of a digestive, kidney, heart, lung and metabolic disease, cancer
2) Individuals who have undergone surgery related to the gastrointestinal tract excluding an operation for appendicitis
3) Over Body Mass Index (BMI) ranging between 19.0 to 30 kg/m2
4) Patient who has taken other preion medicine or Korean herbal medicine within 4 weeks
5) Pregnant and lactating women
6) Severe psychological and mental illness patient, dementia and drug addiction
7) History of another clinical study within the previous 2 months
8) Patient who have abnormal value of blood test results (more than three times over the normal range)
9) Those with difficulty imposing a strict restriction on any oral activities (such as eating, brushing teeth, etc.) for at least 4 hours
10) Patients with hypersensitivity to the test drug
11) Disqualified as a suitable patient by Korean medicine doctor
12) Anyone considered inappropriate for participating in this trial by the clinical study conductors
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional dyspepsia quality of life score
- Secondary Outcome Measures
Name Time Method Tongue coating thickness (%);Result of blood sampling;Spleen qi deficiency questionnaire score