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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT07008235
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or more
* Patients with FD diagnosed according to ROME IV criteria
* Patients who are willing to sign informed written consent
Exclusion Criteria:
* Structural lesion in endoscopy and positive CLO test
* Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
* History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease
* Major medical and psychiatric disorders
* Previous history gastrointestinal surgery
* Any patient with ongoing treatment with antidepressants or antipsychotics
* Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine
* Patients for whom Amitriptyline and Trifluoperazine are contraindicated
* Elderly patients\> 60 years
* Pregnancy and breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07008235
Study Brief:
Protocol Section:
NCT07008235