DRKS00017458已完成4 期
A prospective, open label, single arm post-market study to assess effectiveness and safety of the base composition bath salt („Basis-Zusammensetzung Badesalz) in healthy subjects - BEST
Alexander Weltecke GmbH & Co. KG0 个研究点目标入组 51 人开始时间: 2019年7月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Male or female aged = 18 years on the day of screening
- •2) Subjects able to understand the informed consent and willing to participate as evidenced by providing informed consent.
- •3) Signed Informed Consent
- •4) Subjects able and willing to attend all scheduled visits and comply with all study procedures
排除标准
- •1) Known hypersensitivity to a component of the base composition bath salt
- •2) Open wounds
- •3) Active infections
- •4) Severe generalized disease resulting in a life expectancy shorter than 3 months
- •5) Pregnant or breast-feeding women
- •6) Women of childbearing potential without effective contraception
- •7) Alcohol- or drug abuse
- •8) Subjects with psychiatric disorders influencing their judgement or autonomy
- •9) Inability or unwillingness to understand or comply with required study procedures
- •10) Subjects who are not suitable for the study based on the principal investigator’s evaluation
- •11) Subjects who are financially or otherwise dependent on the principal investigator or sponsor.
- •12) Subjects who are imprisoned or have been institutionalized for medical reasons
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