Urine Specimen Collection
Conditions
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.
Detailed description
To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29.
Interventions
DRUGNephrosolid tablets
Adminstration of drug
Sponsors
A. Vogel AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Willingness and ability to record urine volume and fluid consumption over 3 days. * Written consent to participate in the study.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability as assessed by the treating physician | day 29 | Tolerability is assessed at 2nd visit /study end, after 4 weeks of intake, according to four step scale ( poor, moderate, good, very good) |
Countries
Switzerland
Outcome results
None listed