The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia

NCT03856294 | Completed Phase 2

• 1 other identifier: Rikkunshito1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dyspepsia

Keywords

gastric motility; functional dyspepsia; functional dyspepsia symptoms

Outcome Measures

Primary Outcomes (1)

• Gastric pressure

  Contractions of the stomach and relaxation of the stomach upon food intake

  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

  every 5 minutes, up to 2 hours after administration of the liquid meal

• Gastrointestinal symptoms during treatment period

  On a daily basis throughout the 4-week treatment arms

Study Arms (2)

Rikkunshito

EXPERIMENTAL

Rikkunshito: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake

Drug: Rikkunshito

Placebo

PLACEBO COMPARATOR

Placebo: 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake

Drug: Placebos

Interventions

Rikkunshito DRUG

Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake

Also known as: TJ-43

Rikkunshito

Placebos DRUG

Placebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Tsumura and Company, Tokyo, Japan: collaborator

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

liu-jun-zi-tang

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Tack, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: December 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)