Drug Safety Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
South Africa | Tiger Trial Centre | Tygerberg | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia | National Center for Complementary and Integrative Health (NCCIH), University of the Western Cape |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | Through end of study | Yes | |
Secondary | Change in study drug biomarker levels | Biomarker, Canavanine, was measured | Through end of study | No |
Secondary | Change in appetite | Through end of study | No | |
Secondary | Change in respiration rate | Through end of study | No | |
Secondary | Change in complete blood count | Through end of study | No | |
Secondary | Change in serum protein levels | Through end of study | No | |
Secondary | Change in serum albumin levels | Through end of study | No |
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