EUCTR2014-001864-36-BE进行中（未招募）1 期
A PLACEBO-CONTROLLED STUDY ON THE EFFECT OF RIKKUNSHITO ON GASTRIC ACCOMMODATION AND NUTRIENT TOLERANCE, QUANTIFIED BY INTRAGASTRIC PRESSURE MONITORING DURING INTRAGASTRIC NUTRIENT INFUSION, IN FUNCTIONAL DYSPEPSIA - Proof-of-Concept of Rikkunshito in Functional Dyspepsia
uzleuven0 个研究点目标入组 0 人开始时间: 2015年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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