Primary Care dySpEpsia rikkuNshiTo

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Primary Care dySpEpsia rikkuNshiTo," is studying a treatment called Rikkunshito for patients experiencing postprandial distress syndrome (PDS), a condition characterized by uncomfortable fullness and early satiety after meals. These symptoms can significantly affect daily life, but currently, there are no proven effective treatments available in Europe. The trial aims to compare Rikkunshito to a placebo (a non-active treatment) to see if it helps improve symptoms and reduce inflammation in the stomach area.

To participate, individuals must be at least 18 years old, newly diagnosed with functional dyspepsia, and able to understand study requirements. They should also be using effective birth control methods. However, some individuals may not be eligible, including those with certain medical conditions or who are currently taking specific medications. Participants will be monitored throughout the study and may experience improvements in their symptoms if Rikkunshito proves effective. This trial is not yet recruiting, but it represents an important step towards finding better treatment options for those suffering from dyspeptic symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• • 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
• • 3. Male or female
• • 4. 18 years old or older
• • 5. Newly to be treated FD diagnosis
• • 6. Capable to understand and comply with the study requirements
• Exclusion Criteria:
• • 1. Participant has a history of diabetes mellitus type 1, type 2 (including therapy), eosinophilic esophagitis, coeliac disease or inflammatory bowel disease, major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy).
• • 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. Patients with predominant symtoms of gastro-oesophageal reflux disease (GERD) or irritable bowel syndrome (IBS) 6. Patients with any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) or severe depression using PHQ-7 (score of 20-27) 7. Patients already on PPI therapy20 or using a PPI in the last 2 weeks prior to enrolment 8. Patients with active malignancy (including therapy) 9. Known HIV, HBV, or HCV infection (including therapy) 10. Significant alcohol use (more than 10 units a week) 11. Known allergy to Rikkunshito or any of its ingredients 12. Patients with overweight (BMI\>26)