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

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.