Double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of „Ensinger Schiller Quelle Heilwasser on improvement of bowel function

Ensinger Mineral-Heilquellen GmbH0 个研究点开始时间: 2013年4月18日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•Female and male subjects aged 18 - 64
•BMI < 35 kg/m2
•2-4 bowel movements per week during the last 3 months (according to subject's statement)
•Functional constipation according to the ROME III criteria
•Commitment to adhere to former diet and physical activity
•Subject is used to consuming at least 1000 ml of water (incl. tea) or mineral water daily
•Commitment to only use the IP personally
•Women of childbearing potential: commitment to use contraception methods
•Participation is based upon written informed consent of the participant following written and oral information by the investigator regarding nature, purpose, consequences, and possible risks of the clinical trial
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Clinically relevant excursions of laboratory parameters
•Irritable bowel syndrom
•Acute or chronic disease of the gastrointestinal tract
•Presence of occult blood on screening
•Abdominal surgery within the last 6 months prior to study start
•Known pelvic floor dysfunction
•Acute or chronic kidney or urinary tract disease
•Susceptibility to development of uric acid or calcium-containing kidney stones
•Acute or chronic neurological or psychiatric illness
•Any serious organ or systemic diseases that could influence the
•outcome of the clinical trial
•Known sensitivity to the ingredients of the product
•Use of any preparations that could affect the gastrointestinal tract (e.g. probiotics, laxatives, enema, obstipating drugs etc.) during the last 2 weeks and during the study
•Use of sympathomimetics and cardiac glycosides
•Magnesium and Calcium supplementation during the study
•Intake of mineral water other than the IP during the study
•Pregnancy or nursing (women of childbearing potential)
•Drug, alcohol or medication abuse
•Participation in another clinical trial during the last 30 days prior to study start
•Persons that are in relationship or dependence to the sponsor or the investigator
•subject is a prisoner
•Presence of other factor(s) that, in the in-vestigator’s judgement, should preclude subject participation.

发起方

Ensinger Mineral-Heilquellen GmbH