Dyspepsia and Other Specified Disorders of Function of StomachPhase 3PRESENTNCT06482671
Primary Care dySpEpsia rikkuNshiTo
A Phase 3 study testing Rikkunshi-to in people with Dyspepsia and Other Specified Disorders of Function of Stomach and Postprandial Distress Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia and Other Specified Disorders of Function of Stomach, Postprandial Distress Syndrome
- What is being tested?
- Rikkunshi-to
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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
- Capable to understand and comply with the study requirements
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Jan Tack, MD; PhD, 016344225, jan.tack@uzleuven.be
About this study
Official title: A Randomized Controlled Trial of Rikkunshito (TJ-43) in Functional Dyspepsia Patients Recruited From Primary Care
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.
Read more
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
- Being tested
- Rikkunshi-to, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rikkunshi-toDrug
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
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Rikkunshito | Active comparator | 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. Receives: Drug: Rikkunshi-to |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage responders of Rikkunshito compared to placebo in FD
Number of patients clinically relevant difference of 0.7 for the PDS symptoms (average of 3 questions of LPDS diary) by comparing pretreatment baseline scores with the average score during the last 2 weeks on treatment (responder definition). And compared Rikkunshito versus placebo.
Measured: 8 weeks
Secondary outcomes (10)
The effect of Rikkunshito versus placebo on duodenal mucosal integrity
mucosal permeability and electrical resistance measured by Ussing-Chambers in duodenal biopsies
Measured: 8 weeks
The effect of Rikkunshito versus placebo on Immune activation
Assessment of immune cell counts (mast cells and eosinophils) in duodenal biopsies
Measured: 8 weeks
The effect of Rikkunshito versus placebo on duodenal microbiome
Assessment of DNA of bacteria at the level of duodenal mucosa biopsies
Measured: 8 weeks
percentage minimal clinical response of rikkunshito
Number of patients clinically relevant difference of 0.5 for the PDS symptoms (average of 3 questions of LPDS diary) by comparing pretreatment baseline scores with the average score during the last 2 weeks on treatment (minimal clinical relevant reseponse definition). And compared Rikkunshito versus placebo.
Measured: 8 weeks
The effect of Rikkunshito versus placebo on PDS clinical symptoms
assessed with the LPDS daily diary
Measured: 8 weeks
The effect of Rikkunshito versus placebo on gastrointestinal symptoms
assessed by PAGI-SYM questionnaire
Measured: 8 weeks
The effect of Rikkunshito versus placebo on quality of life
Assessed with the PAGI-Qol questionnaire
Measured: 8 weeks
The effect of Rikkunshito versus placebo on psychologic distress
Assessed by the PHQ questionnaire
Measured: 8 weeks
The response to Rikkunshito in patients with normal versus those with delayed gastric emptying rate at baseline.
assessed with the C13 gastric emptying breath test
Measured: 8 weeks
• The effect of Rikkunshito versus placebo at 8 weeks on gastric emptying rate in those with delayed emptying at baseline.
assessed with the C13 gastric emptying breath test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspepsia and Other Specified Disorders of Function of StomachStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind intervention with Rikkunshito (herbal preparation) or Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482671
- Sponsor's protocol ID
- S69351
- Other IDs
- 2024-515756-20-00
- Acronym
- PRESENT
- Status last verified
- Feb 2025
- First submitted
- 25 Jun 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rikkunshito (TJ-43) in Functional Dyspepsia Patients Recruited From Primary Care
- ClinicalTrials.gov ID
- NCT06482671
- Acronym / sponsor ID
- PRESENT / S69351
- Conditions
- Dyspepsia and Other Specified Disorders of Function of Stomach, Postprandial Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind intervention with Rikkunshito (herbal preparation) or Placebo
| Arm | Type | Receives |
|---|---|---|
| Rikkunshito | Active comparator | Drug: Rikkunshi-toRikkunshito (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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rikkunshi-toKampo 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 | Drug | Rikkunshito |
| Placeboinactive 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). | Other | Placebo |
Primary outcome
Percentage responders of Rikkunshito compared to placebo in FD
Time frame: 8 weeks
Number of patients clinically relevant difference of 0.7 for the PDS symptoms (average of 3 questions of LPDS diary) by comparing pretreatment baseline scores with the average score during the last 2 weeks on treatment (responder definition). And compared Rikkunshito versus placebo.
10 secondary outcomes
The effect of Rikkunshito versus placebo on duodenal mucosal integrity
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on Immune activation
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on duodenal microbiome
Time frame: 8 weeks
percentage minimal clinical response of rikkunshito
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on PDS clinical symptoms
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on gastrointestinal symptoms
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on quality of life
Time frame: 8 weeks
The effect of Rikkunshito versus placebo on psychologic distress
Time frame: 8 weeks
The response to Rikkunshito in patients with normal versus those with delayed gastric emptying rate at baseline.
Time frame: 8 weeks
• The effect of Rikkunshito versus placebo at 8 weeks on gastric emptying rate in those with delayed emptying at baseline.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Related trials for Dyspepsia and Other Specified Disorders of Function of Stomach
RecruitingPhase 2/3
Holy Basil in The Treatment of Dyspepsia
Dyspepsia and Other Specified Disorders of Function of Stomach
RecruitingObservational study
BSGM to Evaluate Patients With GI Symptoms
Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rikkunshi-to in people with Dyspepsia and Other Specified Disorders of Function of Stomach and Postprandial Distress Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack, MD (16 34 42 25 ext. +32, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage responders of Rikkunshito compared to placebo in FD (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.