BridgeMD
PRESENT: Primary care dySpEpsia rikkuNshiTo
EU CTIS ID: 2024-515756-20-00
What this study is testing
Our objective is to study the effect of Rikkunshito on dyspeptic symptoms in FD patients, recruited from primary care in Belgium.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects for wich voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Subjects capable to understand and to comply with the study requirements
- 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.
- Male or female
- 18 years old or older
- 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
You likely can't join if
- 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).
- Known HIV, HBV, or HCV infection
- Significant alcohol use (more than 10 units a week)
- Known allergy to Rikkunshito or any of its ingredients
- Patients with overweight (BMI>26)
- Patients taking prohibited medications (see protocol)
See the full eligibility criteria
Who can join
- Subjects for wich voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Subjects capable to understand and to comply with the study requirements
- 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.
- Male or female
- 18 years old or older
- 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
- 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
What rules you out
- 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).
- Known HIV, HBV, or HCV infection
- Significant alcohol use (more than 10 units a week)
- Known allergy to Rikkunshito or any of its ingredients
- Patients with overweight (BMI>26)
- Patients taking prohibited medications (see protocol)
- Patients with active malignancy
- 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.
- Patients with predominant symtoms of gastro-oesophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
- 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)
- Patients on PPI therapy or using a PPI in the last 2 weeks prior to enrolment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.