Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083980
Status:
TERMINATED
Last Update Posted:
2012-10-19
First Post:
2004-06-04
Brief Title:
Kava Kava for the Treatment of Generalized Anxiety Disorder GAD
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
KAVA KAVA in Generalized Anxiety A Double-Blind Trial
Status:
TERMINATED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
European reports of liver toxicity from kava meant that the study had to stop
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder GAD
Detailed Description:
Kava kava KAV is a plant-derived treatment widely used in Europe to treat anxiety disorders Several studies suggest that KAV may be effective in reducing anxiety symptoms however trial data are limited This study will compare KAV the drug venlafaxine-XR VEN and placebo for the treatment of GAD
This study will last 10 weeks Participants will be randomly assigned to receive KAV VEN or placebo for 8 weeks Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation Self-report scales and questionnaires will be used to assess the anxiety depression and functional impairment of participants Side effects vital signs and laboratory measures will be monitored throughout the study
This study will last 10 weeks Participants will be randomly assigned to receive KAV VEN or placebo for 8 weeks Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation Self-report scales and questionnaires will be used to assess the anxiety depression and functional impairment of participants Side effects vital signs and laboratory measures will be monitored throughout the study
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