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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Sutherlandia frutescens, subspecies microphylla (an herb)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind Placebo Controlled Study to Investigate the Safety of Sutherlandia Frutescens (Subspecies Microphylla) in Health Adult Volunteers.

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

Estimated Enrollment: 24
Study Start Date: July 2004
Study Completion Date: March 2007
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200772

Locations
South Africa
Haylene Nell, MBChB
Bellville, Cape Town, Western Cape, South Africa
Sponsors and Collaborators
University of Missouri-Columbia
University of the Western Cape
Karl Bremer Hospital
Investigators
Principal Investigator: Haylene Nell, MBChB Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200772     History of Changes
Other Study ID Numbers: R21 AT001944-01, R21AT001944-01
Study First Received: September 12, 2005
Last Updated: January 6, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Missouri-Columbia:
Sutherlandia Frutescens
Normal volunteers

ClinicalTrials.gov processed this record on April 17, 2014