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

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.

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 ®).

Study Overview

• Status: Withdrawn
• Conditions: Memory Deficit
• Intervention / Treatment: Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin; Drug: 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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Cotia, São Paulo, Brazil, 06710-670
      • Cliníca Dr. Felício Savioli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours).	Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin; A tablet, 2 times daily (12/12 hours).
Active Comparator: Comparator Group; Ginkgo Biloba (Tebonin ®) - 1 tablet, 2 times a day (12/12 hours).	Drug: Ginkgo Biloba (Tebonin®); A tablet, 2 times daily (12/12 hours).; Other Names: Ginkgo Biloba

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 safety 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 safety of the medication to be prescribed by the observation of adverse events and related to the study medication. Analysis of safety tests (biochemical profile, complete blood count, blood glucose, cholesterol and uric acid) requested at visit 1 and 2.	60 days

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Felício MD Savioli Neto, Cliníca Dr. Felício Savioli

Study record dates

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Disorders of cognitive function
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: GGKEMS0910