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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00987805
Eligibility Criteria:
Inclusion Criteria:
1. Typical functional dyspepsia according to ROME III criteria.
* One or more of:
* Bothersome post-prandial fullness
* Early satiation
* Epigastric pain
* Epigastric burning
* No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
4. Written and informed consent
Exclusion Criteria:
1. History of peptic ulcer or gastroesophageal reflux disease(GERD)
2. Current prominent symptoms of irritable bowel syndrome or GERD
3. Presence of the following alarm symptoms:
* Severe weight loss
* Black or tar stool
* Dysphagia
4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
5. Women in pregnancy and lactation
6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system
7. Participation of other clinical trials within the last 3 months
8. Severe mental problems or drug abuse
9. Judged by expert that they are appropriate to participate in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00987805
Study Brief:
Protocol Section:
NCT00987805