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

Sponsor

A. Vogel AG (Industry)

Overall Status

Completed

CT.gov ID

NCT04338477

Collaborator

(none)

Enrollment

Locations

Arm

11.6

Actual Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urine Specimen Collection	Drug: Nephrosolid tablets	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 12, 2018

Actual Primary Completion Date :

Dec 17, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon	Arbon	Thurgau	Switzerland	9320
2	Private Practice Dr. med Bernhard Waelti	Freidorf	Thurgau	Switzerland	9306

Sponsors and Collaborators

A. Vogel AG

Investigators

Principal Investigator: Bernhard Waelti, Dr. med.,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

A. Vogel AG

ClinicalTrials.gov Identifier:

NCT04338477

Other Study ID Numbers:

920174

First Posted:

Apr 8, 2020

Last Update Posted:

Apr 8, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2020