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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Andrographis and Withania | Experimental | Active ingredient: 550 mg of Andrographis paniculata (standardized to 40 mg andrographolides) and Withania somnifera (standardized to 10 mg withanolides) taken twice daily, once in the morning and once in the evening |
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| Placebo | Placebo Comparator | 550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andrographis and Withania | Dietary Supplement | Combination of Andrographis paniculata and Withania somnifera |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo | 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). | Four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Koch, MD | NeuroCode AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Labors of NeuroCode AG | Wetzlar | D-35578 | Germany |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000713167 | Andrographis paniculata extract |
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| Placebo | Dietary Supplement | Visually identical placebo capsule |
|