A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults

Quinton Johnson, James Syce, Haylene Nell, Kevin Rudeen and William R Folk

PLOS Clinical Trials, 2007, vol. 2, issue 4, 1-7

Abstract: Objectives: Indigenous medicines are widely used throughout Africa, despite a lack of scientific evidence for their safety or efficacy. The aims of this study were: (a) to conduct a pilot study of the safety of a common indigenous South African phytotherapy, Lessertia frutescens (Sutherlandia), in healthy adults; and (b) to contribute to establishing procedures for ethical and scientifically rigorous clinical trials of African indigenous medicines. Design: A randomized, double-blind, placebo-controlled trial of Sutherlandia leaf powder in healthy adults. Setting: Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa. Participants: 25 adults who provided informed consent and had no known significant diseases or allergic conditions nor clinically abnormal laboratory blood profiles during screening. Intervention: 12 participants randomized to a treatment arm consumed 400 mg capsules of Sutherlandia leaf powder twice daily (800 mg/d). 13 individuals randomized to the control arm consumed a placebo capsule. Each participant received 180 capsules for the trial duration of 3 mo. Outcome Measures: The primary endpoint was frequency of adverse events; secondary endpoints were changes in physical, vital, blood, and biomarker indices. Results: There were no significant differences in general adverse events or physical, vital, blood, and biomarker indices between the treatment and placebo groups (p > 0.05). However, participants consuming Sutherlandia reported improved appetite compared to those in the placebo group (p = 0.01). Although the treatment group exhibited a lower respiration rate (p

Date: 2007
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pctr00:0020016

DOI: 10.1371/journal.pctr.0020016

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