Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-31 @ 12:01 PM
Study NCT ID:
NCT01939951
Status:
UNKNOWN
Last Update Posted:
2013-09-11
First Post:
2013-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo in Persistent Asthma.
Sponsor:
California Allergy and Asthma Medical Group, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Parallel Group, Placebo-controlled Study to Compare the Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo on Patients With Mild to Moderate Persistent Asthma.
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
NOT_YET_RECRUITING
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 aims to find out if AES ( Activation Energy Serum) , a blend of natural minerals , is effective and safe for the treatment of asthma if taken for 4 weeks . The efficacy will be scientifically tested by symptoms scores, questionnaires, breathing and blood tests.
Detailed Description:
The primary objective of this study will be to compare the overall efficacy and safety of AES ( Activation Energy Serum) by demonstrating a clinically significant improvement in morning FEV1 in patients with mild to moderate persistent asthma treated with 2 doses of AES for 4 weeks compared to placebo.
The secondary objectives will be to evaluate the effect of AES on a) clinical symptoms by symptom scores and the Asthma Control Questionnaire ( ACQ) , b) fractional exhaled nitric oxide ( FeNO) , c) blood eosinophil count and other biomarkers , and d) quality of life through the Asthma Quality of Life Questionnaire ( AQLQ) .
The secondary objectives will be to evaluate the effect of AES on a) clinical symptoms by symptom scores and the Asthma Control Questionnaire ( ACQ) , b) fractional exhaled nitric oxide ( FeNO) , c) blood eosinophil count and other biomarkers , and d) quality of life through the Asthma Quality of Life Questionnaire ( AQLQ) .
Study Oversight
Has Oversight DMC:
False
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?: