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

March 29, 2012
September 24, 2013
November 2013
June 2014   (final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT01637168 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
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 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Memory Deficit
  • Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
    A tablet, 2 times daily (12/12 hours).
    Other Name: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
  • Drug: Ginkgo Biloba (Tebonin®)
    A tablet, 2 times daily (12/12 hours).
    Other Name: Ginkgo Biloba
  • Experimental: Test Group
    Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours).
    Intervention: Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
  • Active Comparator: Comparator Group
    Ginkgo Biloba (Tebonin ®) - 1 tablet, 2 times a day (12/12 hours).
    Intervention: Drug: Ginkgo Biloba (Tebonin®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
138
September 2014
June 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years to 60 Years
No
Contact: Felipe MD Pinho 55 19 3887 9851 felipe.pinho@ems.com.br
Brazil
 
NCT01637168
GGKEMS0910
Yes
EMS
EMS
Not Provided
Principal Investigator: Felício MD Savioli Neto Clínica Dr. Felício Savioli
EMS
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP