Phase 1 clinical trial for assessment of safety of a multi component botanical formulation SKBSHYAM

SK Biolabs1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2002年1月4日

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: Any toxic side effects after application of SKBSHYAM on skin such as irritation, redness, inflammation, edema, urticaria, fever, vomiting, nausea, faintness, cough, rashes etc.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Multi component botanical formulation SKBSHYAM causes no toxicity in healthy human volunteers.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 20.00 Year(s) 至 81.00 Year(s)（—）
性别: All

入选标准

•Healthy human volunteers.

排除标准

•Patients suffering from any disease.

结局指标

主要结局

Any toxic side effects after application of SKBSHYAM on skin such as irritation, redness, inflammation, edema, urticaria, fever, vomiting, nausea, faintness, cough, rashes etc.

时间窗: 30 minutes

次要结局

Any toxic side effects after application of SKBSHYAM on skin such as irritation, redness, inflammation, edema, urticaria, fever, vomiting, nausea, faintness, cough, rashes etc.(1 month)

研究者

发起方

SK Biolabs

申办方类型

Research institution

研究点 (1)

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