Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029692
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2002-01-18
Brief Title:
Effects of Ginseng and Ginkgo on Drug Disposition in Man
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effects of Ginseng and Ginkgo on Drug Disposition in Man
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This study will assess the effects of ginseng and ginkgo on 1 cognitive function 2 enzymes that process drugs and 3 enzymes that may help prevent cancer
Detailed Description:
Over 60 million Americans use herbal medicines of these one-fourth also take prescription drugs Physicians are often unaware of herbal use and of possible drugherb interactions in their patients Ginseng and ginkgo enhancers of physical and mental performance are two of the most widely taken herbals We propose a double-blind randomized prospective study of effects of ginseng and ginkgo on 1 disposition of probe drugs 2 cognitive function and 3 glutathione-S-transferase GST and quinone reductase NQ01 enzymes implicated in chemoprevention of cancer Probe drugs will be administered to study effects of herbs on their disposition not for therapeutic effect Ideal probes must be safe well tolerated have minimal pharmacological effect and share known metabolic pathways with other clinically used drugs Medically stable drug-free non-smokers will be enrolled
During a 4-week single-blind run-in subjects will be given a 4-drug probe cocktail caffeine to study cytochrome P4501A2 CYP1A2 dextromethorphan for CYP2D6 buspirone and endogenous cortisol for CHP3A and fexofenadine for P-glycoprotein Losartan will be given separately for CYP2C9 These enzymes metabolize over 95 of clinically used drugs Enzyme activities will be determined by assaying appropriate blood and urine specimens for probe drugs and metabolites Cognitive function will be tested and blood lymphocytes collected for measuring GST and NQ01 activities Sixty subjects will then be randomly assigned to one of 4 double-blind treatment groups of 15 each 1 ginseng extract Ginsana 2 ginkgo extract Egb761 3 both herbs or 4 matching placebos Tolerability of herbs will be determined After 6 to 8 weeks of twice daily treatment with study agents all effect parameters will be reevaluated probe drug pharmacokinetics cognitive function and GST and NQ01 in blood lymphocytes Interactions of chronic ginseng and ginkgo with drug-metabolizing pathways and with cognitive function will thus be determined
During a 4-week single-blind run-in subjects will be given a 4-drug probe cocktail caffeine to study cytochrome P4501A2 CYP1A2 dextromethorphan for CYP2D6 buspirone and endogenous cortisol for CHP3A and fexofenadine for P-glycoprotein Losartan will be given separately for CYP2C9 These enzymes metabolize over 95 of clinically used drugs Enzyme activities will be determined by assaying appropriate blood and urine specimens for probe drugs and metabolites Cognitive function will be tested and blood lymphocytes collected for measuring GST and NQ01 activities Sixty subjects will then be randomly assigned to one of 4 double-blind treatment groups of 15 each 1 ginseng extract Ginsana 2 ginkgo extract Egb761 3 both herbs or 4 matching placebos Tolerability of herbs will be determined After 6 to 8 weeks of twice daily treatment with study agents all effect parameters will be reevaluated probe drug pharmacokinetics cognitive function and GST and NQ01 in blood lymphocytes Interactions of chronic ginseng and ginkgo with drug-metabolizing pathways and with cognitive function will thus be determined
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