A Safety Study of Lessertia Frutescens in Adults.

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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, infections and symptoms associated with AIDS. The aim of this study was to evaluate the safety of this phytotherapy in healthy adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Missouri-Columbia
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of the Western Cape

Criteria

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.