Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213298
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-01-09
Brief Title:
Effect of Kava on Anxiety and Stress in Cancer Survivors
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Effect of Kava on Anxiety and Stress in Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 is a pilot two-arm randomized blinded placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment Participants will be randomized to take either kava first or placebo first Kava 75 mg or placebo will be taken three time daily TID for 14 days Period 1 followed by a washout period of 14-28 days Thereafter the participant will take either placebo or kava TID for 14 days Period 2 whichever heshe did not take in Period 1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None