Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-28 @ 3:53 AM
Study NCT ID:
NCT01637168
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders
Sponsor:
EMS
Organization:
Study Overview
Official Title:
Clinical Phase III, Randomized, Double-blind, Prospective Study, for Efficacy and Safety Evaluation of Panax Ginseng + Associations Compared to Ginkgo Biloba in Symptomatic Cognitive Function Disorder Treatment.
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Canceled \[By sponsor decision)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of two different drugs in the treatment of patients diagnosed with memory difficulties and a decline in cognitive function.
This is a parallel distribution: a group of patients will be treated with a combination Panax Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo Biloba (Tebonin ®).
This is a parallel distribution: a group of patients will be treated with a combination Panax Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo Biloba (Tebonin ®).
Detailed Description:
STUDY DESIGN:
* multicenter, phase III, double-blind, randomized entry of patients, prospective and comparative
* The duration of the study: 60 days
* 3 visits (days 1, 30 and 60)
* Evaluate the effectiveness of the association
* Evaluate the safety of the combination
* Adverse events evaluation
* multicenter, phase III, double-blind, randomized entry of patients, prospective and comparative
* The duration of the study: 60 days
* 3 visits (days 1, 30 and 60)
* Evaluate the effectiveness of the association
* Evaluate the safety of the combination
* Adverse events evaluation
Study Oversight
Has Oversight DMC:
True
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?: