A Safety Study of Sutherlandia Frutescens, a South African Medicinal Plant, in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Collaborators:
University of the Western Cape
Karl Bremer Hospital
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00200772
First received: September 12, 2005
Last updated: January 6, 2010
Last verified: January 2010

September 12, 2005
January 6, 2010
July 2004
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Complete list of historical versions of study NCT00200772 on ClinicalTrials.gov Archive Site
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A Safety Study of Sutherlandia Frutescens, a South African Medicinal Plant, in Healthy Adult Volunteers
A Randomized, Double Blind Placebo Controlled Study to Investigate the Safety of Sutherlandia Frutescens (Subspecies Microphylla) in Health Adult Volunteers.

The objective of this study is to investigate the safety of S. frutescens in healthy adult volunteers by assessing liver, kidney, muscle, metabolic, intestinal, cardiac and bone marrow function, as well as physiological and physical status, and to determine whether any of the potential active constituents of the plant is present in the blood of healthy adult volunteers following oral administration of the leaf poweder.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
Drug: Sutherlandia frutescens, subspecies microphylla (an herb)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2007
Not Provided

Inclusion Criteria:

  • Body weight within 25% of the appropriate weight range
  • 12 lead ECG without significant abnormalities
  • able to communicate effictively with study personnel

Exclusion Criteria:

  • Receiving regular medical treatment
  • Hypersensitivity or abnormal reaction to any drugs or herbal products
  • Diseases or conditions that might compromise any body system
  • History of allergic conditions, such as asthma, urticaria, and eczema
  • History or presence of dyspepsia, gastric ulcer or duodenal ulcer
  • History of autoimmune disorders, e.g. systemic lupus erythematosus, hemolytic anemia.
  • History of psychiatric disorders.
  • Intake of any medication within 14 days before start of the study.
  • Scheduled to undergo hospitalization for surgery during the study
  • Recent history of alcoholism or unwillingness to refrain from excessive alcohol consumption during the study.
  • Smokers, who smoke more than 10 cigarettes per day and cannot refreain from smoking during the study period.
  • Clinically significant abnormal laboratory results during screening
  • Pregnancy or breastfeeding
  • Females of childbearing age potential not using medically accepted contraceptive measures, as judged by the investigator.
  • Use of any recreational drugs or a history of drug addiction.
  • Participation in a clinical study or any investigational product 1 month prior to visit 1 or during the study.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00200772
R21 AT001944-01, R21AT001944-01
Yes
Not Provided
University of Missouri-Columbia
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • John E. Fogarty International Center (FIC)
  • Office of Dietary Supplements (ODS)
  • University of the Western Cape
  • Karl Bremer Hospital
Principal Investigator: Haylene Nell, MBChB Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa
University of Missouri-Columbia
January 2010

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