In order to understand this disparity between human use and drugs approved by regulatory agencies, we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide future trials. A total of 195 botanical drug clinical trials were registered from 2016 to 2019, of which 81 are phase II or phase II/III. 95% of all phase II and II/III studies were designed with 100 or less participants per arm, indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control groups. Due to the limited number of participants, efficacy outcome from results may be highly subjective. 14% of the total trials were phase I studies. For botanical drugs with well-documented or extensive history of human use, phase I may not provide significant additional information, and may, therefore, not be necessary. For the trial design, we suggest added-on studies when botanical drugs are used as part of a combination treatment. Additionally, we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.

为了了解人类使用与监管机构批准的药物之间的差异，我们分析了ClinicalTrial.gov上注册的植物药临床试验，以发现当前试验的趋势并指导未来的试验。从2016年到2019年，共注册了195个植物药物临床试验，其中81个处于II期或II / III期。所有II期和II / III期研究中的95％设计为每臂100名或更少的参与者，这表明更具观察性，因为检测治疗组和对照组之间结局差异的能力有限。由于参与者的数量有限，结果的疗效结果可能是高度主观的。总试验中有14％是I期研究。对于具有良好记录或广泛使用历史的植物药，第一阶段可能不会提供重要的附加信息，因此可能没有必要。对于试验设计，我们建议将植物药用作联合治疗的一部分时进行补充研究。此外，我们认为标准化的数据收集方法和标准对于利用大量的人类经验作为质量证据来支持监管批准至关重要。