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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01637168
First received: March 29, 2012
Last updated: September 24, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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).
Other Name: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01637168     History of Changes
Other Study ID Numbers: GGKEMS0910
Study First Received: March 29, 2012
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Disorders of cognitive function

ClinicalTrials.gov processed this record on October 19, 2014