Rikkunshi-to for primary care dyspepsia
A Randomized Controlled Trial of Rikkunshito (TJ-43) in Functional Dyspepsia Patients Recruited From Primary Care
This trial tests whether the herbal medicine rikkunshi-to can relieve symptoms in adults with functional dyspepsia, including postprandial distress syndrome.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06482671 on ClinicalTrials.gov |
What this trial studies
This Phase 3, interventional trial randomizes adults with a new diagnosis of functional dyspepsia to receive either rikkunshi-to or a matching placebo. The study is conducted at KU Leuven and includes participants who can provide informed consent and meet contraception requirements where applicable. The trial builds on prior findings of increased duodenal mucosal permeability and low‑grade inflammation in functional dyspepsia and will compare symptom outcomes between the treatment and placebo groups. Patients with certain comorbidities such as diabetes, celiac disease, inflammatory bowel disease, eosinophilic esophagitis, or major abdominal surgery are excluded.
Who should consider this trial
Good fit: Adults aged 18 or older with a newly made diagnosis of functional dyspepsia (including postprandial distress or epigastric pain syndrome) who can consent, comply with study procedures, and use effective contraception when required.
Not a fit: People with diabetes, celiac disease, inflammatory bowel disease, eosinophilic esophagitis, a history of major abdominal surgery (except appendectomy), or other listed exclusions are not likely to benefit because they are ineligible for this trial.
Why it matters
Potential benefit: If successful, rikkunshi-to could become an effective treatment option to reduce dyspepsia symptoms and improve patients' quality of life.
How similar studies have performed: Previous mechanistic studies have shown duodenal barrier defects and low‑grade inflammation in functional dyspepsia and smaller clinical reports suggest potential benefit from treatments like rikkunshi-to, but robust phase 3 evidence in Europe is lacking.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leuven, Vlaams-Brabant
- KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Jan Tack, MD
- Email: jan.tack@kuleuven.be
- Phone: 16 34 42 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.