Drug SafetyPhase 1NCT00376415
A Safety Study of Lessertia Frutescens in Adults.
A Phase 1 study testing Lessertia Fructescens in people with Drug Safety, run by University of Missouri-Columbia at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- Lessertia Fructescens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2004to Jan 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.
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.
Read the detailed 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.
- Conditions
- Drug Safety
- Being tested
- Lessertia Fructescens, Placebo
- Keywords
- Lessertia frutescens, Sutherlandia frutescens, Phase 1 clinical trial, Human safety study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lessertia FructescensDrug
Also called Sutherlandia Phytotherapy
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
PlaceboDrug
Participants received an identical placebo capsule twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Lessertia Fructescens | Experimental | Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months. Receives: Drug: Lessertia Fructescens |
| Placebo | Placebo comparator | Participants received an identical placebo capsule twice daily for 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Through end of study
Secondary outcomes (6)
Change in study drug biomarker levels
Biomarker, Canavanine, was measured
Measured: Through end of study
Change in appetite
Measured: Through end of study
Change in respiration rate
Measured: Through end of study
Change in complete blood count
Measured: Through end of study
Change in serum protein levels
Measured: Through end of study
Change in serum albumin levels
Measured: Through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startSep 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of the Western Cape
- Responsible party
- Sponsor
- Investigators
- Haylene Nell, MBChB, Principal investigator, Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South AfricaQuinton Johnson, PhD, Study director, South African Herbal Science and Medicine Institute, University of the Western Cape, Bellville, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376415
- Sponsor's protocol ID
- R21AT001944
- Other IDs
- R21AT001944, TICIPS-001
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2006
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.
- ClinicalTrials.gov ID
- NCT00376415
- Acronym / sponsor ID
- R21AT001944
- Conditions
- Drug Safety
- Keywords
- Lessertia frutescens, Sutherlandia frutescens, Phase 1 clinical trial, Human safety study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of the Western Cape
- Study start
- Sep 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 14 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lessertia Fructescens | Experimental | Drug: Lessertia FructescensParticipants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received an identical placebo capsule twice daily for 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lessertia FructescensAlso: Sutherlandia PhytotherapyParticipants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months. | Drug | Lessertia Fructescens |
| PlaceboParticipants received an identical placebo capsule twice daily for 3 months. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Through end of study
6 secondary outcomes
Change in study drug biomarker levels
Time frame: Through end of study
Change in appetite
Time frame: Through end of study
Change in respiration rate
Time frame: Through end of study
Change in complete blood count
Time frame: Through end of study
Change in serum protein levels
Time frame: Through end of study
Change in serum albumin levels
Time frame: Through end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haylene Nell, MBChB principal investigator
Tiger Trial Centre, Karl Bremmer Hospital, Tygerberg, South Africa
Quinton Johnson, PhD study director
South African Herbal Science and Medicine Institute, University of the Western Cape, Bellville, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lessertia Fructescens in people with Drug Safety, run by University of Missouri-Columbia at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Through end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.