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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
  Purpose
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.

Condition Intervention Phase
Drug Safety
Drug: Lessertia Fructescens
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Through end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in study drug biomarker levels [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
    Biomarker, Canavanine, was measured

  • Change in appetite [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
  • Change in respiration rate [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
  • Change in complete blood count [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
  • Change in serum protein levels [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
  • Change in serum albumin levels [ Time Frame: Through end of study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lessertia Fructescens
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
Drug: Lessertia Fructescens
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
Other Name: Sutherlandia Phytotherapy
Placebo Comparator: Placebo
Participants received an identical placebo capsule twice daily for 3 months.
Drug: Placebo
Participants received an identical placebo capsule twice daily for 3 months.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376415

Locations
South Africa
Tiger Trial Centre
Tygerberg, Western Cape, South Africa, 7535
Sponsors and Collaborators
University of Missouri-Columbia
National Center for Complementary and Integrative Health (NCCIH)
University of the Western Cape
Investigators
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
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00376415     History of Changes
Obsolete Identifiers: NCT00200772
Other Study ID Numbers: R21AT001944  TICIPS-001 
Study First Received: September 12, 2006
Last Updated: September 29, 2016
Health Authority: South Africa: Medicines Control Council
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Missouri-Columbia:
Lessertia frutescens
Sutherlandia frutescens
Phase 1 clinical trial
Human safety study

ClinicalTrials.gov processed this record on December 06, 2016