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

Sponsors

Lead Sponsor: Bioforce AG

Source Bioforce AG
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.

Overall Status Completed
Start Date February 12, 2018
Completion Date January 31, 2019
Primary Completion Date December 17, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Tolerability as assessed by the treating physician day 29
Enrollment 66
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nephrosolid tablets

Description: Adminstration of drug

Arm Group Label: Nephrosolid

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role
Bernhard Waelti, Dr. med. Principal Investigator
Location
Facility:
Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon | Arbon, Thurgau, 9320, Switzerland
Private Practice Dr. med Bernhard Waelti | Freidorf, Thurgau, 9306, Switzerland
Location Countries

Switzerland

Verification Date

April 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Nephrosolid

Type: Experimental

Description: Acute 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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov