A Phase 1 interventional study of Lessertia Fructescens and Placebo in Drug Safety, sponsored by University of Missouri-Columbia. Completed at 1 site in South Africa. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-30.
Sponsored by University of Missouri-Columbia · Phase 1, Interventional, and Basic science
Lessertia frutescens (L.) Goldblatt \& J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to combat cancer, infections and symptoms associated with AIDS. The aim of this study was to evaluate the safety of this phytotherapy in healthy adults.
Objectives: Lessertia frutescens (L.) Goldblatt \& J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to combat cancer, infections and symptoms associated with AIDS. The aim of this study was to evaluate the safety of this phytotherapy in healthy adults.
Design: A randomised, double blind, placebo-controlled trial to evaluate the safety of Lessertia frutescens in healthy adults.
Setting: Karl Bremer Hospital, Bellville, South Africa.
Participants: 25 adults, aged 18 to 45 years, who provided informed consent. They had no significant diseases or clinically abnormal laboratory blood profiles during screening. They had no history of allergic conditions and were not on regular medical treatment.
Intervention: 12 healthy participants were randomized to a treatment arm where they received 400mg L. frutescens leaf powder capsules twice daily (800mg/day), available as a product called Sutherlandia. 13 healthy participants were randomized to the control arm, where they received an identical placebo capsule. The trial lasted 3 months.
Outcome Measures: The primary endpoint was frequency of adverse events and the secondary endpoint, changes in physical, vital, blood and biomarker indices.
Results: There were no significant differences in general adverse events, cardiovascular, CNS, GIT, infection, allergy, malaise, most physical, haematological, biochemical or physiological parameters, between the treatment and the placebo groups (P>0.05). However, subjects consuming L. frutescens mostly reported improved appetite compared to those in the placebo group (P\<0.01). Although the treatment group exhibited a lower respiration rate (P\<0.04), higher platelet count (P\<0.03), MCH (P\<0.01), MCHC (P\<0.02), total protein (P\<0.03) and albumin levels (P\<0.03), than the placebo group, these differences remained within the normal physiological range, and were not clinically relevant. The L. frutescens biomarker, Canavanine, was undetectable in subject plasma.
Conclusion: Overall, consumption of 800mg/day L. frutescens leaf powder capsules, was well tolerated by healthy adults.
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Healthy males and females between 18 and 45 years of age will:
Exclusion Criteria:
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
Drug: Lessertia Fructescens
Participants received an identical placebo capsule twice daily for 3 months.
Drug: Placebo
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
Also known as: Sutherlandia Phytotherapy
Participants received an identical placebo capsule twice daily for 3 months.
Number of participants with adverse events
Time frame: Through end of study
Change in study drug biomarker levels
Biomarker, Canavanine, was measured
Time frame: Through end of study
Change in appetite
Time frame: Through end of study
Change in respiration rate
Time frame: Through end of study
Change in complete blood count
Time frame: Through end of study
Change in serum protein levels
Time frame: Through end of study
Change in serum albumin levels
Time frame: Through end of study
Plan to share: Undecided
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The record gives a start of Sep 2004, a primary completion of Jan 2005 and a completion of Jan 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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