The effect of rikkunshito, a traditional Japanese herbal medicine, on stomach functions of patients with functional dyspepsia

Phase 1

• Conditions: functional dyspepsia - postprandial distress syndrome; MedDRA version: 18.0Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-001864-36-BE
• Lead Sponsor: uzleuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-30
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

At visit 1(Diagnosis before assessment of the activity of the disease by LPDS):

1.Patients with FD diagnosis as per Rome III

2.Patients must provide witnessed written informed consent prior to any study procedures being performed

3.Patients aged between 18 and 75 years inclusive

4.Male or female patients

5.Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements

At visit 2 (Evaluation of the activity of the disease by LPDS before randomisation):

6.Patients suffering from active PDS (Rome III) as per LPDS scoring system during the 2 weeks eligibility period.
At least moderate Postprandial fullness and/or early satiation should be present at least 4 days during the 2 weeks eligibility period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study

2.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 mirtazapin which are forbidden) during the last 3 months are eligible.

3.Females who are pregnant or lactating. Females who refuse to take appropriate contraception at the time of informed consent.

4.Men who want to donate sperm during the study and during the 4 weeks after stopping Rikkunshito.

5.Patients who received treatment for HP eradication during the last 3 months. Patients who are HP positive may enter the study provided that their endoscopy is negative. HP status will be taken at visit 1.

6.Patients suffering from diabetes type 1 or type 2.

7.Patients taking drugs affecting the gut secretion, mucosal integrity (NSAIDs with an exception for aspirin at cardioprotective dose of max 125 mg daily), motility, and/or sensitivity. Patients taking PPIs are eligible provided that FD is predominant and heartburn limited to maximum two episodes of mild intensity per week.

8.Patients with coronary heart disease, arrhythmias or taking concomitant drugs capable to prolong the QT.

9.Patients taking concomitant drugs able to induce drug-drug interaction (P450).

10.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.

11.Patients with known hypersensitivity to the Ginseng or Ginger.

12.Patients with confirmed gastro-intestinal disease.

13.Patients with former digestive surgery affecting upper gut motility.

14.Patients affected by concomitant extra-digestive disease responsible for digestive symptoms.

15.Patients presenting with predominant symptoms of irritable bowel syndrome (IBS).

16.Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 or higher on question 10).

17.Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 or higher on question 9).

18.Patients presenting vomiting more than one day a month.

19.Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19).

20.Patients presenting predominant GERD (3 yes” by GERD questionnaire).

21.Patients not willing to take UV protective measures or patients at increased risk for phototoxicity (use of drugs like tetracyclins, amiodarone, sulphonamides, quinolones).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified