Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118833
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2005-07-07
Brief Title:
St Johns Wort for the Treatment of Generalized Social Anxiety Disorder GSAD
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder GSAD
Status:
COMPLETED
Status Verified Date:
2007-09
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:
This study will determine whether the herbal product St Johns wort is safe and effective in treating generalized social anxiety disorder GSAD
Study hypothesis Hypericum perforatum St Johns wort is more effective in treating GSAD than placebo
Study hypothesis Hypericum perforatum St Johns wort is more effective in treating GSAD than placebo
Detailed Description:
The use of complementary and alternative medicine CAM has grown dramatically over the last decade Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression Evidence suggests that the botanical St Johns wort has neurochemical activity similar to that of conventional medications However research on the safety and effectiveness of St Johns wort is limited This study will determine the safety and effectiveness of St Johns wort in treating GSAD a serious condition characterized by intense fear of various social situations that may cause embarrassment
Participants will be randomly assigned to receive either St Johns wort or placebo daily for 10 weeks Self-report scales will be used to assess participants GSAD symptoms at study entry and at study completion Blood collection will occur at every weekly study visit to determine the levels of St Johns wort in the blood
Participants will be randomly assigned to receive either St Johns wort or placebo daily for 10 weeks Self-report scales will be used to assess participants GSAD symptoms at study entry and at study completion Blood collection will occur at every weekly study visit to determine the levels of St Johns wort in the blood
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