Status:
COMPLETED
A Safety Study of Lessertia Frutescens in Adults.
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
University of the Western Cape
Conditions:
Drug Safety
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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, infe...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00376415
Start Date
September 1 2004
End Date
January 1 2005
Last Update
September 30 2016
Active Locations (1)
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1
Tiger Trial Centre
Tygerberg, Western Cape, South Africa, 7535