None listed
Conditions
Interventions
Trade Name: Ensinger Schiller Quelle Heilwasser
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Heilwasser
Other descriptive name: Heilwasser with the main ingredients calcium, magnesium, sulpha
Sponsors
Ensinger Mineral-Heilquellen GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female and male subjects aged 18 - 64 • BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is the change of bowel movement frequency per week between baseline and visit 4 compared to placebo. ;Secondary Objective: • Change in the number of bowel movements per week • Change in the number of bowel movements during study duration • Change in stool consistency • Changes in gastrointestinal well-being • Change in general well-being • Change in liver and lipid metabolism function laboratory parameters • Change in gut flora parameters • Change in waist and hip circumference • Change in body weight and blood pressure • Global evaluation of efficacy by both investigators and subjects • Global evaluation of tolerability by both investigators and subjects • Safety laboratory parameters;Primary end point(s): Difference in the change of bowel movements per week, from baseline to visit 4 between verum and placebo;Timepoint(s) of evaluation of this end point: The change of bowel movements per week will be assessed by comparison of the number of bowel movements in the week before Visit 4 and the week before baseline . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in the number of bowel movements per week compared to placebo • Change in the number of bowel movements during the study course compared to placebo • Change in stool consistency compared to placebo • Changes in gastrointestinal well-being compared to placebo • Change in general well-being compared to placebo • Change in liver and lipid metabolism function laboratory parameters compared to placebo • Change in body weight and blood pressure compared to placebo • Change in waist and hip circumference compared to placebo • Global evaluation of efficacy and tolerability by both investigators and subjects • Safety Laboratory parameters ;Timepoint(s) of evaluation of this end point: • Bowel movements frequency: Baseline and at V3 • Bowel movements frequency: time course of the study (diary) • Stool consistency: Baseline and at V3/V4 • Gastrointestinal well-being baseline and at V3/V4 • General well-being: baseline and at V3/V4 • Liver and lipid metabolism function laboratory parameters: baseline and at V3/V4 • Gut flora parameters: screening Visit and at V4 • Body weight/blood pressure: baseline and at V3/V4 • Waist and hip circumference: baseline and at V3/V4 • Global evaluation of efficacy and tolerability: V4 • Laboratory parameters: screening Visit and V4 | — |
Countries
Germany
Contacts
Public ContactThomas Fritz
Ensinger Mineral-Heilquellen GmbH
Outcome results
None listed