Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers
Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers
1 other identifier
interventional
66
1 country
2
Brief Summary
Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2018
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedApril 8, 2020
April 1, 2020
10 months
January 4, 2018
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability as assessed by the treating physician
Tolerability is assessed at 2nd visit /study end, after 4 weeks of intake, according to four step scale ( poor, moderate, good, very good)
day 29
Study Arms (1)
Nephrosolid
EXPERIMENTALAcute dosis day 1: 3X2 Nephrosolid tablets 0.5 h before intake of a meal Long-term dosis days 2-28: 2x1 Nephrosolid tablets 0.5 h before intake of a meal
Interventions
Eligibility Criteria
You may qualify if:
- Willingness and ability to record urine volume and fluid consumption over 3 days.
- Written consent to participate in the study.
You may not qualify if:
- Disease or comprehension problems (language) that affect the accurate collection and measurement of urine levels over 3 days.
- Taking diuretic drugs, teas, herbal supplements, or systemic corticosteroids.
- Chronic nephropathy (such as glomerulonephritis, analgesic nephropathy, interstitial nephritis).
- Pregnancy or lactation.
- Psychiatric disorders that include suicidality.
- Surgical intervention in the 3 months prior to enrollment or scheduled surgery during the study.
- Known chronic diseases such as dementia, progressive systemic diseases.
- Known alcohol and/or drug addiction.
- Known allergies to goldenrod or birch leaves.
- Participation in one or more other clinical trials in the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- A. Vogel AGlead
Study Sites (2)
Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon
Arbon, Thurgau, 9320, Switzerland
Private Practice Dr. med Bernhard Waelti
Freidorf, Thurgau, 9306, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Bernhard Waelti, Dr. med.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2018
First Posted
April 8, 2020
Study Start
February 12, 2018
Primary Completion
December 17, 2018
Study Completion
January 31, 2019
Last Updated
April 8, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share