Author
Listed:
- Quinton Johnson
- James Syce
- Haylene Nell
- Kevin Rudeen
- William R Folk
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
Suggested Citation
Quinton Johnson & James Syce & Haylene Nell & Kevin Rudeen & William R Folk, 2007.
"A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults,"
PLOS Clinical Trials, Public Library of Science, vol. 2(4), pages 1-7, April.
Handle:
RePEc:plo:pctr00:0020016
DOI: 10.1371/journal.pctr.0020016
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