A Safety Study of Lessertia Frutescens in Adults.

NCT00376415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-09-30

No results posted yet for this study

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.

Conditions

  • Drug Safety

Interventions

DRUG

Lessertia Fructescens

Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.

DRUG

Placebo

Participants received an identical placebo capsule twice daily for 3 months.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • University of the Western Cape

    collaborator OTHER
  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Haylene Nell, MBChB · Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa

  • Quinton Johnson, PhD · South African Herbal Science and Medicine Institute, University of the Western Cape, Bellville, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • South Africa

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00376415 on ClinicalTrials.gov