Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders

NCT ID: NCT01637168

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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

Conditions

Memory Deficit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group

Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours).

Group Type: EXPERIMENTAL

Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin

Intervention Type: DRUG

A tablet, 2 times daily (12/12 hours).

Comparator Group

Ginkgo Biloba (Tebonin ®) - 1 tablet, 2 times a day (12/12 hours).

Group Type: ACTIVE_COMPARATOR

Ginkgo Biloba (Tebonin®)

Intervention Type: DRUG

A tablet, 2 times daily (12/12 hours).

Interventions

Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin

A tablet, 2 times daily (12/12 hours).

Intervention Type: DRUG

Ginkgo Biloba (Tebonin®)

A tablet, 2 times daily (12/12 hours).

Intervention Type: DRUG

Other Intervention Names

Ginkgo Biloba

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felício MD Savioli Neto

Role: PRINCIPAL_INVESTIGATOR

Clínica Dr. Felício Savioli

Locations

Cliníca Dr. Felício Savioli

Cotia, São Paulo, Brazil

Countries

Brazil

Other Identifiers

GGKEMS0910

Identifier Type: -

Identifier Source: org_study_id