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

NCT01637168 | Withdrawn Phase 3 DMC

• 1 other identifier: GGKEMS0910
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 ®).

Conditions

Memory Deficit

Keywords

Disorders of cognitive function

Outcome Measures

Primary Outcomes (1)

• 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.

  To evaluate the efficacy of the association between Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin to treat patients with disorders of cognitive function compared to treatment with the drug Ginkgo Biloba (Tebonin ®) The assessment of effectiveness will be determined by statistical evaluation of the scores of responses related to quality of life questionnaires and psychometric tests (Mini-Mental Test and Test of Logical Memory WMS-R).

  60 days

Secondary Outcomes (1)

• 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.

  60 days

Study Arms (2)

Test Group

EXPERIMENTAL

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

Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin

Comparator Group

ACTIVE COMPARATOR

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

Drug: Ginkgo Biloba (Tebonin®)

Interventions

Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin DRUG

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

Test Group

Ginkgo Biloba (Tebonin®) DRUG

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

Also known as: Ginkgo Biloba

Comparator Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of any race, sex, aged 18-60 years;
• 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);
• Consent of the patient (Signature of the IC);
• Patients are able to read and write;
• "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.
• Women of childbearing potential must submit βHCG negative serum;
• Patients are able to understand and carry out the study procedures;

You may not qualify if:

• Patients with hypersensitivity to the components of the formula;
• Patients who are making use of levodopa or salicylates;
• Routine use of medications that alter cognitive functions such as barbiturates, anticonvulsants, benzodiazepines, neuroleptics, alcohol and illicit drugs;
• Pregnant or lactating women;
• Participation in another clinical trial with investigational medication in the last 3 months;
• Patients with prior knowledge of infectious disease;
• 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.
• 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;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Cliníca Dr. Felício Savioli

Cotia, São Paulo, 06710-670, Brazil

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Asian ginseng; Ginkgo Extract; Geritol; Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Felício MD Savioli Neto

  Clínica Dr. Felício Savioli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: July 11, 2012
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

BR (1)