A Safety Study of Lessertia Frutescens in Adults.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Screening
|Official Title:||A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.|
- The primary endpoint of this study was adverse events, incidence (number) and type recorded during a three-month treatment period.
- The secondary endpoints of this study were:
- Changes in physical examination & vital signs: weight, blood pressure, heart rate, respiratory rate, body temperature from baseline to end of treatment; Changes in haematological and biochemical parameters from baseline to end of treatment;
- Active constituent levels of the Sutherlandia biomarker, Canavanine.
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||January 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376415
|Tiger Trial Centre|
|Tygerberg, Western Cape, South Africa, 7535|
|Principal Investigator:||Haylene Nell, MBChB||Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa|
|Study Director:||Quinton Johnson, PhD||South African Herbal Science and Medicine Institute, University of the Western Cape, Bellville, South Africa|