NCT00376415

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 12, 2006

Last Update Submit

September 29, 2016

Conditions

Drug Safety

Keywords

Lessertia frutescensSutherlandia frutescensPhase 1 clinical trialHuman safety study

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Through end of study

Secondary Outcomes (6)

  • Change in study drug biomarker levels

    Through end of study

  • Change in appetite

    Through end of study

  • Change in respiration rate

    Through end of study

  • Change in complete blood count

    Through end of study

  • Change in serum protein levels

    Through end of study

  • +1 more secondary outcomes

Study Arms (2)

Lessertia Fructescens

EXPERIMENTAL

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

Drug: Lessertia Fructescens

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lessertia FructescensDRUG

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

Also known as: Sutherlandia Phytotherapy
Lessertia Fructescens
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiger Trial Centre

Tygerberg, Western Cape, 7535, South Africa

Location

Study Officials

  • Haylene Nell, MBChB

    Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa

    PRINCIPAL INVESTIGATOR

  • Quinton Johnson, PhD

    South African Herbal Science and Medicine Institute, University of the Western Cape, Bellville, South Africa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 14, 2006

Study Start

September 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

ZA(1)