Status:
COMPLETED
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
Lead Sponsor:
Seoul National University Hospital
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
The goal of this study is to evaluate the feasibility of a decentralized clinical trial in South Korea. The main questions it aims to answer are: * Does decentralized elements feasible in Korea? * Do...
Detailed Description
The trial aims to evaluate decentralized elements in South Korea, including clinical laboratory testing using local laboratories, medication adherence assessment using wearable devices, analysis of se...
Eligibility Criteria
Inclusion
- 1\) Inclusion Criteria
- Adults aged 19 to 75 years old at the time of consent.
- The sum of the intensity and frequency score of the six major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, belching and nausea) of the self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) is 12 or more.
- 2\) Exclusion Criteria
- Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract.
- Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis.
- Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.
- Pregnant or lactating women
- Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered.
- Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests
- Subjects who are expected to take other medications within the study period that may affect the evaluation of the effectiveness of the study substance (gastrointestinal motility promoters, acid secretagogues, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, anticholinergics, erythromycin, corticosteroids, antidepressants, etc.
- Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.
Exclusion
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06005805
Start Date
August 21 2023
End Date
October 31 2023
Last Update
November 22 2023
Active Locations (1)
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1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea, 03080