A Safety Study of Lessertia Frutescens in Adults.

Drug Safety Clinical Trial

Official title:

A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376415
• Other study ID #: R21AT001944
• Secondary ID: R21AT001944TICIP
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2006
• Last updated: September 29, 2016
• Start date: September 2004
• Est. completion date: January 2005

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Design: A randomised, double blind, placebo-controlled trial to evaluate the safety of Lessertia frutescens in healthy adults.

Setting: Karl Bremer Hospital, Bellville, South Africa.

Participants: 25 adults, aged 18 to 45 years, who provided informed consent. They had no significant diseases or clinically abnormal laboratory blood profiles during screening. They had no history of allergic conditions and were not on regular medical treatment.

Intervention: 12 healthy participants were randomized to a treatment arm where they received 400mg L. frutescens leaf powder capsules twice daily (800mg/day), available as a product called Sutherlandia. 13 healthy participants were randomized to the control arm, where they received an identical placebo capsule. The trial lasted 3 months.

Outcome Measures: The primary endpoint was frequency of adverse events and the secondary endpoint, changes in physical, vital, blood and biomarker indices.

Results: There were no significant differences in general adverse events, cardiovascular, CNS, GIT, infection, allergy, malaise, most physical, haematological, biochemical or physiological parameters, between the treatment and the placebo groups (P>0.05). However, subjects consuming L. frutescens mostly reported improved appetite compared to those in the placebo group (P<0.01). Although the treatment group exhibited a lower respiration rate (P<0.04), higher platelet count (P<0.03), MCH (P<0.01), MCHC (P<0.02), total protein (P<0.03) and albumin levels (P<0.03), than the placebo group, these differences remained within the normal physiological range, and were not clinically relevant. The L. frutescens biomarker, Canavanine, was undetectable in subject plasma.

Conclusion: Overall, consumption of 800mg/day L. frutescens leaf powder capsules, was well tolerated by healthy adults.

Other known NCT identifiers

• NCT00200772

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• Lessertia Fructescens
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
• Placebo
Participants received an identical placebo capsule twice daily for 3 months.

Locations

Country	Name	City	State
South Africa	Tiger Trial Centre	Tygerberg	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	National Center for Complementary and Integrative Health (NCCIH), University of the Western Cape

Country where clinical trial is conducted

South Africa, 

Outcome

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