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

Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.

Study Overview

• Status: Completed
• Conditions: Urine Specimen Collection
• Intervention / Treatment: Drug: Nephrosolid tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Arbon, Thurgau, Switzerland, 9320
      • Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon
    • Freidorf, Thurgau, Switzerland, 9306
      • Private Practice Dr. med Bernhard Waelti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nephrosolid; 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	Drug: Nephrosolid tablets; Adminstration of drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: A. Vogel AG
• Investigators: Principal Investigator: Bernhard Waelti, Dr. med.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2018
• Primary Completion (ACTUAL): December 17, 2018
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 920174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No