Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376415
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2006-09-12
Brief Title:
A Safety Study of Lessertia Frutescens in Adults
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lessertia frutescens L Goldblatt JC 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 JC 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 800mgday 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 P005 However subjects consuming L frutescens mostly reported improved appetite compared to those in the placebo group P001 Although the treatment group exhibited a lower respiration rate P004 higher platelet count P003 MCH P001 MCHC P002 total protein P003 and albumin levels P003 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 800mgday L frutescens leaf powder capsules was well tolerated by 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 800mgday 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 P005 However subjects consuming L frutescens mostly reported improved appetite compared to those in the placebo group P001 Although the treatment group exhibited a lower respiration rate P004 higher platelet count P003 MCH P001 MCHC P002 total protein P003 and albumin levels P003 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 800mgday L frutescens leaf powder capsules was well tolerated by healthy adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TICIPS-001 | OTHER_GRANT | NCCIH | httpsreporternihgovquickSearchR21AT001944 |
| R21AT001944 | NIH | None | None |