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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01921504
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 \~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
* One who meet Rome III FD criteria\* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
* One or more of the following:
1. Bothersome postprandial fullness
2. Early satiation
3. Epigastric pain
4. Epigastric burning
* One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
* One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
* One who receives no other treatments during the study
* One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion Criteria:
* One who has peptic ulcer or gastroesophageal reflux disease (GERD)
* One who has obvious signs of irritable bowel syndrome (IBS)
* One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
* One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
* One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
* One who is pregnant or breastfeeding
* One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
* One who is HIV-positive
* One who has a problem of malabsorption or maldigestion
* One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
* One who does not want to sign the informed consents
* One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01921504
Study Brief:
Protocol Section:
NCT01921504