Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558006
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Safety and Efficacy Predimenol for Headache
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Predimenol for Headache A Preliminary Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective double-blind placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache
Detailed Description:
Predimenol is a bioactive fraction extracted from Phaleria macrocarpa pericarpium Mahkota Dewa
There will be 20 subjects per group a total of 60 subjects planned to be enrolled in the study
The investigational drug tablet 200 mg of Predimenol Dose administration one singe dose two tablets of Predimenol or Placebo
There will be 20 subjects per group a total of 60 subjects planned to be enrolled in the study
The investigational drug tablet 200 mg of Predimenol Dose administration one singe dose two tablets of Predimenol or Placebo
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