Clinical trial NCT01637168: Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Memory Deficit
Keywords: Disorders of cognitive function
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ®).

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

Eligibility criteria: Inclusion Criteria:

1. Patients of any race, sex, aged 18-60 years;
2. Patients presenting two or more symptoms associated with disorders of cognitive function such as memory impairment, poor concentration, depressed mood, decreased mental capacity, provided they score value is below 24 in the evaluation of the psychometric test (Mini Test-mental and WMS-R Logical Memory);
3. Consent of the patient (Signature of the IC);
4. Patients are able to read and write;
5. "Washout" of at least two weeks of the start of the study, in case of use of multivitamins or any other medication for symptomatic treatment of disorders of cognitive function.
6. Women of childbearing potential must submit βHCG negative serum;
7. Patients are able to understand and carry out the study procedures;

Exclusion Criteria:

1. Patients with hypersensitivity to the components of the formula;
2. Patients who are making use of levodopa or salicylates;
3. Routine use of medications that alter cognitive functions such as barbiturates, anticonvulsants, benzodiazepines, neuroleptics, alcohol and illicit drugs;
4. Pregnant or lactating women;
5. Participation in another clinical trial with investigational medication in the last 3 months;
6. Patients with prior knowledge of infectious disease;
7. Patients who are taking other multivitamins or any other medications for the symptomatic treatment of disorders of cognitive function, at least two weeks prior to study initiation.
8. Patients with organic dementias such as Alzheimer's, Pick's disease, Creutzfeldt-Jacob Disease, Huntington's, Parkinson's disease, dementia caused by human immunodeficiency virus (HIV), hypothyroidism, vascular dementia (arteriosclerotic dementia), dementia senile among others;

Primary outcomes:
measure: Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin ®) for the symptomatic treatment of disorders of cognitive function.
timeFrame: 60 days
Secondary outcomes:
measure: Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin ®) for the symptomatic treatment of disorders of cognitive function.
timeFrame: 60 days
Other outcomes:
Locations:
city: Cotia
country: Brazil
facility: Cliníca Dr. Felício Savioli
state: São Paulo
Study officials:
affiliation: Clínica Dr. Felício Savioli
name: Felício MD Savioli Neto
role: PRINCIPAL_INVESTIGATOR
References: