1 Tiervlei Trial Centre (TTC), Karl Bremer Hospital , Bellville, Cape Town, South Africa .
J Altern Complement Med. 2013 Nov;19(11):898-904. doi: 10.1089/acm.2012.0185. Epub 2013 Feb 26.
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,(®) in healthy adult volunteers over a three-month period.
This was a randomized, double-blind, parallel-group, placebo-controlled single center study.
Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, Cape Town, South Africa.
The study took place between February 2 and July 27, 2009. Thirty-seven healthy adults were recruited from the general population.
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.
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).
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.
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.
本研究旨在评估南非药用植物 Sceletium tortuosum（L.）N.E. Br. 2:1 标准化提取物（商标名为 Zembrin，®）的两个剂量（每日一次 8 毫克和 25 毫克）在健康成年志愿者中的安全性和耐受性，为期三个月。
这是一项随机、双盲、平行组、安慰剂对照的单中心研究。
南非开普敦贝维尔的 Tiervlei 试验中心，Karl Bremer 医院。
该研究于 2009 年 2 月 2 日至 7 月 27 日进行，从普通人群中招募了 37 名健康成年人。
参与者被随机分配接受两种剂量的研究药物之一，或接受相同的安慰剂，每日一次，持续 3 个月。在 37 名受试者中，分别有 12、12 和 13 名受试者接受了 8 毫克提取物 Sceletium tortuosum（Zembrin）、25 毫克提取物 Sceletium tortuosum（Zembrin）和安慰剂治疗。
在生命体征、体格检查、12 导联心电图（ECG）、实验室评估（血液学、生物化学和尿液分析）和不良事件（AE）记录方面，三种治疗方法之间没有明显差异。从筛查到 3 个月治疗结束，体重和体检均无明显变化。在初始筛查和研究结束时，血液学或生物化学参数均无显著变化。两种剂量的 Sceletium tortuosum 提取物（Zembrin）均耐受良好。最常见的不良反应是头痛，其次是腹痛和上呼吸道感染，这些不良反应在安慰剂组的发生率均高于治疗组。一些服用 Sceletium tortuosum 提取物（Zembrin）的患者在患者日记中报告了未经请求的积极的幸福感改善，包括改善应对压力和睡眠。
在健康人体中，每日一次使用 Sceletium tortuosum 提取物（Zembrin）的两个剂量（8 毫克和 25 毫克），连续使用 3 个月是安全耐受的。
