含有卡瓦和克拉的多剂量液体混合物的安全性在健康成年人中
Jaustin Dufour1, Xinjie Lois Lin1, Jun Wang2
1Medical Writing, Nutrasource Pharmaceutical and Nutraceutical Services Inc., Guelph, CAN.
Cureus
|January 14, 2025
概括
在一项短期研究中,卡瓦和克拉混合物Feel Free® Classic Tonic (FFCT) 被发现对健康成年人来说安全. 发现了轻微的不良事件,但对生命体征或戒断症状没有显著影响.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 草药的安全性 草药的安全性
- 临床试验 临床试验
背景情况:
- 卡瓦和克拉有着悠久的传统用途,但对它们的安全性数据有限.
- 了解联合卡瓦和克拉补充剂的安全概况对于公众健康至关重要.
- 感觉免费®经典调味剂 (FFCT) 是一种含有卡瓦和克拉的液体混合物.
研究的目的:
- 评估健康成年人每天三种不同剂量的FFCT的安全性和耐受性.
- 评估短期FFCT补充剂对生命体征,临床化学和血液学的影响.
- 用验证的尺度 (COWS和SOWS) 监测任何戒断症状.
主要方法:
- 采用了一种随机,双盲,安慰剂控制的试验设计.
- 参与者连续六天每天接受FFCT或安慰剂的三剂之一.
- 安全性通过生命体征监测,实验室测试和戒断症状尺度 (COWS,SOWS) 来评估.
主要成果:
- 一般来说,FFCT是安全的,有轻度到中度的不良事件,如恶心和头痛,主要是在高剂量组.
- 没有观察到肝脏或脏功能的显著变化;生命体征保持在正常范围内.
- 在统计学上显著,但在临床上没有显著的血压和呼吸速率的变化. 牛和猪的分数没有显示出临床上显著的增加.
结论:
- 在健康的成年人中,短期补充FFCT似乎是安全的.
- 该研究发现对生命体征,实验室值或戒断症状没有显著的不良影响.
- 进一步的研究可能会探索不同人群的长期安全性和影响.
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