Primary Care dySpEpsia rikkuNshiTo

NCT ID: NCT06482671

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-10-01

Brief Summary

Dyspepsia refers to chronic or recurrent upper gastrointestinal (GI) symptoms originating from the gastroduodenal region with a significant impact on patients' lives. Functional dyspepsia comprises the diagnostic categories of epigastric pain syndrome (EPS) with epigastric pain or burning and postprandial distress syndrome (PDS) with meal-related fullness or early satiation, which are unexplained after routine investigation including upper GI endoscopy 2. Despite the common occurrence of FD in up to 15% of the general population, the underlying pathophysiology remains unclear and no treatments of proven efficacy are available in Europe for this condition.

Our group has demonstrated increased duodenal mucosal permeability and low-grade inflammation in FD patients, correlating with meal-related symptoms. The causes of the barrier defect and immune activation are unknown but candidates include psychological stress, luminal food components, (bile) acid and microbiota. The symptoms most closely associated with increased eosinophil counts in the duodenum are early satiation and postprandial fullness, which are typical PDS symptoms, and which are also associated with impaired gastric accommodation to meal ingestion and delayed gastric emptying.

Previously the efficacy of the Kampo medicine Rikkunshito (TJ-43) has been shown in FD. The exact mode of action remains to be determined. Previous studies have provided mechanistic evidence that rikkunshito is able to improve gastric accommodation, improve food intake and enhance circulating levels of the orexigenic gut peptide ghrelin.

The aim of this study is to evaluate the efficacy of Rikkunshito in comparison to placebo in PDS patients recruited from primary care in Belgium, and to evaluate whether this is associated with changes in duodenal mucosal low-grade inflammation.

Conditions

Dyspepsia and Other Specified Disorders of Function of Stomach; Postprandial Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rikkunshito

Rikkunshito (TJ-43) Route of administration: P.O.; dose: 2.5 grams 3 times per day. Needs to be dissolved in about 30 ml of lukewarm water 30 minutes prior to the meal and swallowed as a single dose over approximately one minute at most.

Group Type: ACTIVE_COMPARATOR

Rikkunshi-to

Intervention Type: DRUG

Kampo medicine (Herbal). ikkunshito is composed of the following eight herbal medicines: extracts of Atractylodes lancea Rhizome, Ginseng, Pinellia tuber, Poria sclerotium, Jujube, Citrus unshiu Peel, Glycyrrhiza, and Ginger. Among these, the extracts of the Atractylodes lancea Rhizome, Ginseng, Poria sclerotium, Pinellia tuber, Citrus unshiu Peel, and Glycyrrhiza

Placebo

Placebo Route of administration: P.O.; dose: 2.5 grams 3 times per day Needs to be dissolved in about 30 ml of lukewarm water 30 minutes prior to the meal and swallowed as a single dose over approximately one minute at most.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

inactive drug, The matching placebo contains Corn Starch (vehicle), Lactose Hydrate (vehicle), Dextrin (vehicle), Magnesium Stearate (lubricant), FD\&C Blue No.1 Aluminum Lake (coloring agent), FD\&C Yellow No.5 Aluminum Lake (coloring agent), and Red Ferric Oxide (coloring agent).

Interventions

Rikkunshi-to

Kampo medicine (Herbal). ikkunshito is composed of the following eight herbal medicines: extracts of Atractylodes lancea Rhizome, Ginseng, Pinellia tuber, Poria sclerotium, Jujube, Citrus unshiu Peel, Glycyrrhiza, and Ginger. Among these, the extracts of the Atractylodes lancea Rhizome, Ginseng, Poria sclerotium, Pinellia tuber, Citrus unshiu Peel, and Glycyrrhiza

Intervention Type: DRUG

Placebo

inactive drug, The matching placebo contains Corn Starch (vehicle), Lactose Hydrate (vehicle), Dextrin (vehicle), Magnesium Stearate (lubricant), FD\&C Blue No.1 Aluminum Lake (coloring agent), FD\&C Yellow No.5 Aluminum Lake (coloring agent), and Red Ferric Oxide (coloring agent).

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack, MD

Role: CONTACT

jan.tack@kuleuven.be

16 34 42 25 ext. +32

Facility Contacts

Jan Tack, MD; PhD

Role: primary

jan.tack@uzleuven.be

016344225

Other Identifiers

2024-515756-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

S69351

Identifier Type: -

Identifier Source: org_study_id