Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders
Primary Purpose
Memory Deficit
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
Ginkgo Biloba (Tebonin®)
Sponsored by
About this trial
This is an interventional treatment trial for Memory Deficit focused on measuring Disorders of cognitive function
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
Sites / Locations
- Cliníca Dr. Felício Savioli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Group
Comparator Group
Arm Description
Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours).
Ginkgo Biloba (Tebonin ®) - 1 tablet, 2 times a day (12/12 hours).
Outcomes
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01637168
Brief Title
Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Canceled [By sponsor decision)
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 ®).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficit
Keywords
Disorders of cognitive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours).
Arm Title
Comparator Group
Arm Type
Active Comparator
Arm Description
Ginkgo Biloba (Tebonin ®) - 1 tablet, 2 times a day (12/12 hours).
Intervention Type
Drug
Intervention Name(s)
Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
Intervention Description
A tablet, 2 times daily (12/12 hours).
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba (Tebonin®)
Other Intervention Name(s)
Ginkgo Biloba
Intervention Description
A tablet, 2 times daily (12/12 hours).
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
60 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felício MD Savioli Neto
Organizational Affiliation
Clínica Dr. Felício Savioli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliníca Dr. Felício Savioli
City
Cotia
State/Province
São Paulo
ZIP/Postal Code
06710-670
Country
Brazil
12. IPD Sharing Statement
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Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders
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