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OpenTrials
Completed

NCT Number: NCT04338477

Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nephrosolid tablets

Drug

Adminstration of drug

Primary outcomes

  1. Tolerability as assessed by the treating physician

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

A. Vogel AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 8, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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