Status:
COMPLETED
The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Tsumura and Company, Tokyo, Japan
Conditions:
Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 Ja...
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 wa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- 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).
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03856294
Start Date
December 1 2015
End Date
October 1 2018
Last Update
March 1 2019
Active Locations (1)
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1
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000