A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Extract Sceletium tortuosum (Zembrin) in Healthy Adults
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Extract Sceletium tortuosum (Zembrin) in Healthy Adults
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DOI：
10.1089/acm.2012.0185
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发表时间：
2013-11-01
影响因子：
2.6
通讯作者：
Gericke, Nigel
中科院分区：
文献类型：
--
作者：
Nell, Haylene;Siebert, Mirna;Gericke, Nigel
目的：本研究的目的是评估南非药用植物 Sceletium tortuosum (L.) N.E. 两种剂量（每天一次 8 毫克和 25 毫克）2:1 标准化提取物的安全性和耐受性。 Br.，注册商标为 Zembrin,(R)，在健康成年志愿者中进行为期三个月的研究。设计：这是一项随机、双盲、平行组、安慰剂对照的单中心研究。地点：南非开普敦贝尔维尔卡尔布雷默医院 Tiervlei 试验中心。参与者：该研究于 2009 年 2 月 2 日至 7 月 27 日期间进行。从一般人群中招募了 37 名健康成年人。干预：参与者被随机分配接受两剂研究药物中的一剂或相同的安慰剂，每天服用一次，持续 3 个月。在 37 名受试者中，12、12 和 13 名受试者分别接受 8 mg Sceletium tortuosum 提取物 (Zembrin)、25 mg Sceletium tortuosum 提取物 (Zembrin) 和安慰剂治疗。 结果测量：未评估疗效变量。安全性和耐受性变量包括生命体征、体格检查、12 导联心电图 (ECG)、实验室评估（血液学、生化和尿液分析）以及不良事件 (AE) 记录。结果：从筛选到 3 个月治疗期结束，三种治疗之间在生命体征、12 导联心电图、体重和体格检查方面没有明显差异。从初始筛选到研究结束，没有观察到血液学或生物化学参数发生显着变化。两种剂量的 Sceletium tortuosum (Zembrin) 提取物均具有良好的耐受性。最常见的不良事件是头痛，其次是腹痛和上呼吸道感染，安慰剂组的发生率均高于治疗组。一些服用 Sceletium tortuosum (Zembrin) 提取物的参与者在患者日记中注意到，对健康产生了主动的积极影响，包括改善压力应对和睡眠。结论：健康人类受试者每天使用一次连续 3 个月时，两种剂量的 Sceletium tortuosum (Zembrin) 提取物（8 毫克和 25 毫克）的耐受性良好。
Objectives: The objective of the study was to evaluate the safety and tolerability of two doses (8 mg and 25 mg once daily) of a 2:1 standardized extract of the South African medicinal plant Sceletium tortuosum (L.) N.E. Br., trademarked Zembrin,(R) in healthy adult volunteers over a three-month period.Design: This was a randomized, double-blind, parallel-group, placebo-controlled single center study.Setting: Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, Cape Town, South Africa.Participants: The study took place between February 2 and July 27, 2009. Thirty-seven healthy adults were recruited from the general population.Intervention: Participants were randomized to receive either one of two doses of study medication, or an identical placebo, taken once daily for 3 months. Of the 37 subjects, 12, 12, and 13 subjects received 8 mg extract Sceletium tortuosum (Zembrin), 25 mg extract Sceletium tortuosum (Zembrin), and placebo treatment, respectively.Outcome measures: No efficacy variables were assessed. The safety and tolerability variables comprised of vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory assessments (hematology, biochemistry, and urinalysis), and the recording of adverse events (AEs).Results: There were no apparent differences between the three treatments with regard to vital signs, 12-lead ECG, body weight, and physical examination from screening to the end of the 3-month treatment period. No significant changes were observed in hematology or biochemistry parameters between initial screening and the end of the study. Both doses of extract Sceletium tortuosum (Zembrin) were well-tolerated. The most commonly reported AE was headache, followed by abdominal pain and upper respiratory tract infections, all with greater incidence in the placebo group than in the treatment groups. Unsolicited positive effects on well-being were noted in patient diaries by some participants taking extract Sceletium tortuosum (Zembrin), including improved coping with stress and sleep.Conclusion: Both doses of extract Sceletium tortuosum (Zembrin) (8 mg and 25 mg) were well tolerated when used by healthy human subjects once daily for 3 months.