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A Safety Study of Lessertia Frutescens in Adults.

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
University of the Western Cape
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00376415
First received: September 12, 2006
Last updated: September 29, 2016
Last verified: September 2016
September 12, 2006
September 29, 2016
September 2004
January 2005   (Final data collection date for primary outcome measure)
Number of participants with adverse events [ Time Frame: Through end of study ]
The primary endpoint of this study was adverse events, incidence (number) and type recorded during a three-month treatment period.
Complete list of historical versions of study NCT00376415 on ClinicalTrials.gov Archive Site
  • Change in study drug biomarker levels [ Time Frame: Through end of study ]
    Biomarker, Canavanine, was measured
  • 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 ]
  • 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.
Not Provided
Not Provided
 
A Safety Study of Lessertia Frutescens in Adults.
A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.
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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Drug Safety
  • Drug: Lessertia Fructescens
    Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
    Other Name: Sutherlandia Phytotherapy
  • Drug: Placebo
    Participants received an identical placebo capsule twice daily for 3 months.
  • Experimental: Lessertia Fructescens
    Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
    Intervention: Drug: Lessertia Fructescens
  • Placebo Comparator: Placebo
    Participants received an identical placebo capsule twice daily for 3 months.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
January 2005
January 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy males and females between 18 and 45 years of age will:

  • be informed of the nature of the study and will give written informed consent;
  • have body weights within 25% of the appropriate range;
  • have no significant decreases or clinically abnormal laboratory values during screening;
  • have 12 lead ECG without significant abnormalities;
  • be on no regular medical treatment;
  • be able to communicate effectively with study personnel.

Exclusion Criteria:

  • Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous system, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
  • History of allergic conditions - asthma, urticaria and eczema.
  • History of autoimmune disorders - Lupus erythematosis.
  • History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
  • History of psychiatric disorders.
  • Intake of any medication within 14 days before the start of the study.
  • Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
  • Smokers who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period.
  • Presence of clinically significant abnormal laboratory results during screening.
  • Pregnancy or not using appropriate means of contraception.
  • Use of any recreational drugs or a history of drug addiction.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT00376415
R21AT001944( U.S. NIH Grant/Contract )
R21AT001944 ( U.S. NIH Grant/Contract )
TICIPS-001 ( Other Grant/Funding Number: NCCIH )
Yes
Not Provided
Plan to Share IPD: Undecided
University of Missouri-Columbia
University of Missouri-Columbia
  • National Center for Complementary and Integrative Health (NCCIH)
  • University of the Western Cape
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
University of Missouri-Columbia
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP