DyspepsiaPhase 2NCT03856294
The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia
A Phase 2 study testing Rikkunshito in people with Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Functional dyspepsia (FD) is a common chronic gastrointestinal (GI) disorder. Rikkunshito, a traditional Japanese Kampo medicine, has shown efficacy in improving FD symptoms in controlled trials in Japan. Its putative benefit for European patients has never been investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Rikkunshito
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with FD-postprandial distress syndrome subtype diagnosis as per Rome IV
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 75 years inclusive
- Male or female patients. Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
Who cannot join
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). However, patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline and mirtazapine which are forbidden) during the last 3 months are eligible.
- Females who are pregnant or lactating. Females who refuse to take appropriate contraception at the time of informed consent.
- Men who want to donate sperm during the study and during the 4 weeks after stopping Rikkunshito.
- Patients who received treatment for Helicobacter Pylori (HP) eradication during the last 3 months. Patients who are HP positive may enter the study provided that their endoscopy is negative. If HP status is unknown, determination of HP status will be done during run-in.
- Patients suffering from diabetes type 1 or type 2.
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- Patients taking drugs affecting the gut secretion, mucosal integrity (non-steroidal anti-inflammatory drugs (NSAIDs), with an exception for aspirin at cardioprotective dose of max 125 mg daily), motility, and/or sensitivity. Patients taking proton pump inhibitors (PPIs) are eligible provided that FD is predominant and heartburn limited to maximum two episodes of mild intensity per week.
- Patients with coronary heart disease, arrhythmias or taking concomitant drugs capable to prolong the QT.
- Patients taking concomitant drugs able to induce drug-drug interaction (P450), Concomitant drugs interacting substantially with the different fractions of cytochromes (CYP3A4 and others) and with strong protein binding (Albumine, i-globulins, acid glycoproteins) are excluded.
- Patients with a significant renal [serum creatinine >2 x upper limit of normal (ULN)], hepatic [alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyltransferase (GGT), bilirubin >2 x ULN], cardiovascular, pulmonary, endocrine, metabolic or haematological condition.
- Patients with known hypersensitivity to the Ginseng or Ginger.
- Patients with confirmed gastro-intestinal disease.
- Patients with former digestive surgery affecting upper gut motility.
- Patients affected by concomitant extra-digestive disease responsible for digestive symptoms.
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS).
- Patients presenting symptoms of epigastric pain syndrome (EPS) several times a week, not related to meals, according to Rome III questionnaire (score 5 or higher on question 10, in combination with clinical judgement).
- Patients presenting daily symptoms of nausea syndrome, not related to meals, on Rome III questionnaire (score 6 on question 6 or score 5 or higher on question 9).
- Patients presenting vomiting more than one day a month.
- Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19, in combination with clinical judgement).
- Patients presenting predominant gastro-esophageal reflux disease (GERD) (3 "yes" by GERD questionnaire, in combination with clinical judgement).
- Patients not willing to take ultraviolet protective measures or patients at increased risk for phototoxicity (use of drugs like tetracyclins, amiodarone, sulphonamides, quinolones).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled Study on the Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance, Quantified by Intragastric Pressure Monitoring During Intragastric Nutrient Infusion, in Functional Dyspepsia
Functional dyspepsia (FD) is a common chronic gastrointestinal (GI) disorder. Rikkunshito, a traditional Japanese Kampo medicine, has shown efficacy in improving FD symptoms in controlled trials in Japan. Its putative benefit for European patients has never been investigated. Further, its exact mechanism of action is incompletely elucidated. This study aimed to examine the effect of rikkunshito on gastric motility and GI symptom perception in FD in a randomized, placebo-controlled, cross-over study. Intragastric pressure (IGP) was assessed using high-resolution manometry as an indirect measurement of gastric accommodation and gastric motility.
Read the detailed description
This randomized, placebo-controlled, double-blind, cross-over study had a total duration of 14 weeks, consisting of a two-week run-in period, two treatment phases of four weeks each and a four-week washout period separating the treatment phases to prevent carry-over effects. Study visits were held at baseline (screening) and after the run-in period, treatment phases and washout period.
To assess the effect of rikkunshito on intragastric pressure as an indirect measure for gastric motility, high-resolution manometry (HRM) was performed after the run-in period and after both treatment phases. During intragastric pressure measurement, a nutrient tolerance test was performed and symptom questionnaires were completed. Throughout the entire study, patients scored their gastrointestinal symptoms on a daily basis in the Leuven Postprandial Distress Scale (LPDS) diary. In addition, questionnaires on gastrointestinal symptoms and psychosocial state were completed each study visit.
Safety measures performed each study visit included blood pressure, heart rate and weight assessment, performing an electrocardiogram, adverse event evaluation and physical examination. Furthermore, blood samples were collected during screening and after each treatment phase to check liver and kidney function. Serum levels of potassium, creatine kinase, aspartate aminotransferase, alanine transaminase, alkaline phosphatase and gamma- glutamyltransferase were assessed. Women of childbearing potential were asked to do a pregnancy test before study enrollment and before each treatment period.
- Conditions
- Dyspepsia
- Being tested
- Rikkunshito, Placebos
- Keywords
- gastric motility, functional dyspepsia, functional dyspepsia symptoms
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RikkunshitoDrug
Also called TJ-43
Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
PlacebosDrug
Placebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
| Study group | Role | What they receive |
|---|---|---|
| Rikkunshito | Experimental | Rikkunshito: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake Receives: Drug: Rikkunshito |
| Placebo | Placebo comparator | Placebo: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric pressure
Contractions of the stomach and relaxation of the stomach upon food intake
Measured: Gastric pressure was measured until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after rikkunshito/placebo intake
Secondary outcomes (2)
Gastrointestinal symptoms during gastric pressure measurement
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Measured: every 5 minutes, up to 2 hours after administration of the liquid meal
Gastrointestinal symptoms during treatment period
change in subjective gastrointestinal symptom scores throughout both treatment arms
Measured: On a daily basis throughout the 4-week treatment arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Tsumura and Company, Tokyo, Japan
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856294
- Sponsor's protocol ID
- Rikkunshito1
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Study on the Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance, Quantified by Intragastric Pressure Monitoring During Intragastric Nutrient Infusion, in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03856294
- Acronym / sponsor ID
- Rikkunshito1
- Conditions
- Dyspepsia
- Keywords
- gastric motility, functional dyspepsia, functional dyspepsia symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Tsumura and Company, Tokyo, Japan
- Study start
- Dec 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 27 Feb 2019 (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.
Functional dyspepsia (FD) is a common chronic gastrointestinal (GI) disorder. Rikkunshito, a traditional Japanese Kampo medicine, has shown efficacy in improving FD symptoms in controlled trials in Japan. Its putative benefit for European patients has never been investigated. Further, its exact mechanism of action is incompletely elucidated. This study aimed to examine the effect of rikkunshito on gastric motility and GI symptom perception in FD in a randomized, placebo-controlled, cross-over study. Intragastric pressure (IGP) was assessed using high-resolution manometry as an indirect measurement of gastric accommodation and gastric motility.
Detailed description
This randomized, placebo-controlled, double-blind, cross-over study had a total duration of 14 weeks, consisting of a two-week run-in period, two treatment phases of four weeks each and a four-week washout period separating the treatment phases to prevent carry-over effects. Study visits were held at baseline (screening) and after the run-in period, treatment phases and washout period.
To assess the effect of rikkunshito on intragastric pressure as an indirect measure for gastric motility, high-resolution manometry (HRM) was performed after the run-in period and after both treatment phases. During intragastric pressure measurement, a nutrient tolerance test was performed and symptom questionnaires were completed. Throughout the entire study, patients scored their gastrointestinal symptoms on a daily basis in the Leuven Postprandial Distress Scale (LPDS) diary. In addition, questionnaires on gastrointestinal symptoms and psychosocial state were completed each study visit.
Safety measures performed each study visit included blood pressure, heart rate and weight assessment, performing an electrocardiogram, adverse event evaluation and physical examination. Furthermore, blood samples were collected during screening and after each treatment phase to check liver and kidney function. Serum levels of potassium, creatine kinase, aspartate aminotransferase, alanine transaminase, alkaline phosphatase and gamma- glutamyltransferase were assessed. Women of childbearing potential were asked to do a pregnancy test before study enrollment and before each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rikkunshito | Experimental | Drug: RikkunshitoRikkunshito: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with FD-postprandial distress syndrome subtype diagnosis as per Rome IV
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 75 years inclusive
- Male or female patients. Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
Key exclusion criteria (21 listed)
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). However, patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline and mirtazapine which are forbidden) during the last 3 months are eligible.
- Females who are pregnant or lactating. Females who refuse to take appropriate contraception at the time of informed consent.
- Men who want to donate sperm during the study and during the 4 weeks after stopping Rikkunshito.
- Patients who received treatment for Helicobacter Pylori (HP) eradication during the last 3 months. Patients who are HP positive may enter the study provided that their endoscopy is negative. If HP status is unknown, determination of HP status will be done during run-in.
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 |
|---|---|---|
| RikkunshitoAlso: TJ-43Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake | Drug | Rikkunshito |
| PlacebosPlacebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake | Drug | Placebo |
Primary outcome
Gastric pressure
Time frame: Gastric pressure was measured until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after rikkunshito/placebo intake
Contractions of the stomach and relaxation of the stomach upon food intake
2 secondary outcomes
Gastrointestinal symptoms during gastric pressure measurement
Time frame: every 5 minutes, up to 2 hours after administration of the liquid meal
Gastrointestinal symptoms during treatment period
Time frame: On a daily basis throughout the 4-week treatment arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jan Tack, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rikkunshito in people with Dyspepsia, 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 1 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric pressure (time frame: Gastric pressure was measured until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after rikkunshito/placebo intake). 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 1 Mar 2019.