Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers

Urine Specimen Collection Clinical Trial

Official title:

Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338477
• Other study ID #: 920174
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2020
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 31, 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Urine Specimen Collection

Intervention

Drug:
• Nephrosolid tablets
Adminstration of drug

Locations

Country	Name	City	State
Switzerland	Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon	Arbon	Thurgau
Switzerland	Private Practice Dr. med Bernhard Waelti	Freidorf	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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