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

A. Vogel AG

Status and phase: Completed; Phase 3

Conditions: Urine Specimen Collection

Treatments: Drug: Nephrosolid tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04338477

920174

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Nephrosolid

Experimental group

Description:

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

Treatment:

Drug: Nephrosolid tablets