Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255307
Status:
COMPLETED
Last Update Posted:
2007-06-18
First Post:
2005-11-16
Brief Title:
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection
Sponsor:
CV Technologies
Organization:
Afexa Life Sciences Inc
Study Overview
Official Title:
A Pilot Evaluation of Two Dosing Schedules of American Ginseng Extract in Pediatric Upper Respiratory Tract Infection
Status:
COMPLETED
Status Verified Date:
2007-06
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 randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against placebo in pediatric upper respiratory tract infections URTI It is hypothesized that CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years
Detailed Description:
The eligible children for whom parental consent has been obtained will be randomized to one of three groups standard dose low dose or placebo The standard dose group will receive an oral aqueous solution using the standard dose of CVT-E002 adjusted according to the childs weight The second group will receive an oral aqueous solution with half of the standard dose of CVT-E002 adjusted according to the childs weight and the third group will receive a placebo as an aqueous solution of starch that does not contain any CVT-E002 or active medication volume adjusted for the childs weight Parents will be provided with a 3-day supply of study medication according to the randomization schedule CVT-E002 will be administered by the parent to the child three times daily for three consecutive days following the onset of a URTI Severity and duration of URTI will be measured using the reliable and valid Canadian Acute Respiratory Infection Flu Score CARIFS
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