Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT05693259
Eligibility Criteria:
Inclusion Criteria:
* Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation)
* No evidence of structural disease in gastroscopy within the last 3 months
* Aged 19-70 years
* Who meets Rome IV criteria for functional dyspepsia
* Who have 4 or more symptoms based on the gastrointestinal symptom rating scale
* Patients who voluntarily agree to participate in this study and sign a written consent
Exclusion Criteria:
* Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded
* Subjects who have uncontrolled diabetes and hypertension despite appropriate management
* Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded
* Subject who have history of gastrointestinal surgery were excluded
* Women who are pregnant or breastfeeding
* Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.)
* Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health
* Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05693259
Study Brief:
Protocol Section:
NCT05693259