A Safety Study of Lessertia Frutescens in Adults.
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lessertia Fructescens; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.; Participants received an identical placebo capsule twice daily for 3 months.
Other intervention name(s): Sutherlandia Phytotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Lessertia frutescens; Sutherlandia frutescens; Phase 1 clinical trial; Human safety study