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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by EMS.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637168
First Posted: July 11, 2012
Last Update Posted: September 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EMS
  Purpose

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 ®).


Condition Intervention Phase
Memory Deficit Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin Drug: Ginkgo Biloba (Tebonin®) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • 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. [ Time Frame: 60 days ]

    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).



Secondary Outcome Measures:
  • 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. [ Time Frame: 60 days ]

    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.



Estimated Enrollment: 138
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ginkgo Biloba

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637168


Contacts
Contact: Felipe MD Pinho 55 19 3887 9851 felipe.pinho@ems.com.br

Locations
Brazil
Cliníca Dr. Felício Savioli Not yet recruiting
Cotia, São Paulo, Brazil, 06710-670
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Felício MD Savioli Neto Clínica Dr. Felício Savioli
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01637168     History of Changes
Other Study ID Numbers: GGKEMS0910
First Submitted: March 29, 2012
First Posted: July 11, 2012
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by EMS:
Disorders of cognitive function

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms