Cognitive Impairment, Mild
Conditions
Keywords
Electroencephalography, Andrographis, Ashwagandha
Brief summary
A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a safe and effective treatment for cognitive deficits.
Interventions
DIETARY_SUPPLEMENTAndrographis and Withania
Combination of Andrographis paniculata and Withania somnifera
DIETARY_SUPPLEMENTPlacebo
Visually identical placebo capsule
Sponsors
EuroPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female volunteers suffering from cognitive deficits. * Questionnaire-DemTect. DemTect (for pre-selection of subjects) - score values 8-12 are regarded as conclusive. * Age between 60 and 75 years (both included). * Subjects should be right-handed. * Subject must be capable of giving informed consent. * Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).
Exclusion criteria
* Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded. * Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. * Clinically relevant allergic symptoms. * Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history. * Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history. * Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic). * Presence of a rare, genetic disease such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency (anamnestic). * Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day). * Detection of alcohol at the time of initial examination as well as on day A, B, C and D (alcohol test). * Smoking in the study center on study days A, B, C and D. * Result of the DemTect Questionnaire score \<8 or \>12. * Participation in another clinical trial within the last 60 days. * Bad compliance. * Cancellation of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo | Four weeks | Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during the test of cognitive performance: d2-test for attention (d2-Test), memory test (ME-Test), concentration-performance-test with financial reward (CPT-Test). |
Countries
Germany
Outcome results
None listed