Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Tolerability as assessed by the treating physician
研究概览
简要总结
Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness and ability to record urine volume and fluid consumption over 3 days.
- •Written consent to participate in the study.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Nephrosolid tablets (Drug)
结局指标
主要结局
Tolerability as assessed by the treating physician
时间窗: 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)
次要结局
未报告次要终点