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

NCT ID: NCT04338477

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2019-01-31

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.

Conditions

Urine Specimen Collection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nephrosolid tablets

Intervention Type: DRUG

Adminstration of drug

Interventions

Nephrosolid tablets

Adminstration of drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

A. Vogel AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Waelti, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Locations

Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon

Arbon, Thurgau, Switzerland

Private Practice Dr. med Bernhard Waelti

Freidorf, Thurgau, Switzerland

Countries

Switzerland

Other Identifiers

920174

Identifier Type: -

Identifier Source: org_study_id