RIKKUNSHITO for Functional dyspepsia

Inclusion criteria

• {"criterion_text":"- Subjects for wich voluntary written informed consent of the participant has been obtained prior to any screening procedures\n- Subjects capable to understand and to comply with the study requirements\n- 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.\n- Male or female\n- 18 years old or older\n- Newly to be treated FD diagnosis (as per Rome criteria and assessed with the questionnaire in Aprendix 3). Rome Criteria includes: One or more of the following: Bothersome postprandial fullness, Bothersome early satiation, Bothersome epigastric pain, Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms **Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis\n- FD defined by moderate bothersome postprandial fullness or early satiation for 2 to 5 days per week evaluated by the LPDS diary during 2 week of run-in period"}

Exclusion criteria

• {"criterion_text":"- 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).\n- Known HIV, HBV, or HCV infection\n- Significant alcohol use (more than 10 units a week)\n- Known allergy to Rikkunshito or any of its ingredients\n- Patients with overweight (BMI>26)\n- Patients taking prohibited medications (see protocol)\n- Patients with active malignancy\n- 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.\n- Patients with predominant symtoms of gastro-oesophageal reflux disease (GERD) or irritable bowel syndrome (IBS)\n- 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)\n- Patients on PPI therapy or using a PPI in the last 2 weeks prior to enrolment"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study is to evaluate the therapeutic effect of Rikkunshito on functional dyspepsia symptoms. This will be assessed by the previously validated Leuven Postprandial Distress Scale (LPDS) diary. The percentage of response after treatment with Rikkunshito compared to placebo. The response rate is assessed with the LPDS daily diary (19). A responder is defined by the clinically relevant difference of 0.7 for the LPDS score (average of 3 PDS questions).","definition_or_measurement_approach":"Assessed by the Leuven Postprandial Distress Scale (LPDS) daily diary; response rate compared Rikkunshito versus placebo. A responder is defined by a clinically relevant difference of 0.7 for the LPDS score (average of 3 PDS questions)."}

Secondary endpoints

• {"endpoint_text":"- The effect of Rikkunshito versus placebo on duodenal mucosal parameters before and after treatment.","definition_or_measurement_approach":"Duodenal mucosal parameters measured before and after treatment (specific histological/mucosal assessments as per protocol)."}
• {"endpoint_text":"- The effect of Rikkunshito versus placebo on individual PDS and EPS clinical symptoms, assessed with the LPDS daily diary symptom questionnaire during the 8 weeks therapy.","definition_or_measurement_approach":"Individual PDS and EPS symptoms assessed using LPDS daily diary over the 8-week treatment period."}
• {"endpoint_text":"- The effect of Rikkunshito versus placebo on clinical symptoms, assessed with the LPDS daily diary with a minimum clinically important difference of 0.5 for the PDS symptoms (average of 3 questions) by comparing pretreatment baseline scores with the average score during the last 2 weeks on treatment (responder definition).","definition_or_measurement_approach":"LPDS diary comparison of baseline vs average score during last 2 weeks on treatment; MCID of 0.5 for PDS symptoms (average of 3 questions) used for responder definition."}
• {"endpoint_text":"- The effect of Rikkunshito versus placebo on quality of life, depression, anxiety and somatization co-morbidity, evaluated by the PAGI-Qol and PHQ questionnaires","definition_or_measurement_approach":"Quality of life and psychological comorbidity measured by PAGI-QoL and PHQ questionnaires."}
• {"endpoint_text":"- The effect of Rikkunshito versus placebo on upper gastrointestinal symptoms, evaluated by the PAGI-SYM questionnaire.","definition_or_measurement_approach":"Upper GI symptoms measured by PAGI-SYM questionnaire."}

Methods

• Website (K2_Recruitment material_Website) – study information posted online for potential participants.
• Intranet text (K2_Recruitment material_Intranet tekst) – internal communication to healthcare staff.
• Printed folders/flyers for pharmacy and UZL (K2_Recruitment material_Folder voor apotheek en UZL) – information distributed at hospital pharmacy and UZ Leuven sites.
• Folders for general practitioners (K2_Recruitment material _Folder voor HA) and posters for GPs (HA) – materials targeted at primary care physicians to refer eligible FD patients.
• Posters for pharmacy and UZL (K2_Recruitment material_Poster apotheek en UZL) – on-site recruitment materials at pharmacies and hospital.
• Table card (K2_Recruitment material_Tafelkaart) and posters (K2_Recruitment material_Poster HA) – local point-of-care materials for patients and clinicians.
• Recruitment arrangements document (K1_Recruitment Arrangement) describing planned recruitment organisation and channels.

Belgium

Earliest CTIS Part Ii Submission Date

28-11-2024

Latest Decision Or Authorization Date

26-01-2026

Processing Time Days

424

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Contract research organisations

Name

Almac Clinical Services

Responsibilities

GMP IMP and placebo

Third parties

• {"country":"Japan","full_name":"Almac Clinical Services","duties_or_roles":"GMP IMP and placebo","organisation_type":"Industry"}
• {"country":"","full_name":"TSUMURA & Co.","duties_or_roles":"Monetary support","organisation_type":"Industry"}