Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Co… (NCT04492241) | Clinical Trial Compass
UnknownNot Applicable
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome
China800 participantsStarted 2021-07-05
Plain-language summary
This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution.
Who can participate
Age range60 Years – 85 Years
SexALL
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Inclusion Criteria:
* Sign the informed consent form
* Capability of independent living (capability of dressing, bathing, walking, and bed-chair transfer)
* Met Motoric Cognitive Risk Syndrome (MCR) criteria:
Single task slow gait ( male 60 to 74 y, gait \<75.4 cm/s; male ≥ 75 y, gait \< 59.1 cm/s; female 60 to 74 y, gait \<70.0 cm/s; female ≥ 75 y, gait \< 48.3 cm/s) And The Montreal Cognitive Assessment (MoCA) ≤ 26 (≥ 12 education year) or MoCA ≤ 25 (\< 12 education year)
* Anticipated good compliance per protocol
Exclusion Criteria:
* Illiteracy
* The Mini-Mental State Examination (MMSE) ≤ 23
* Medical history of mental illness such as schizophrenia, severe anxiety and depression.
* Medical history of Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease.
* Dementia caused by other causes (such as central nervous system trauma, tumor, infection, metabolic disease, normal pressure hydrocephalus, folic acid, vitamin B12 deficiency, thyroid Inferior functions, etc.).
* History of epilepsy, or taking anti-epileptic drugs.
* History of myocardial infarction or stroke
* History of malignant tumor
* Coagulation disorder, systemic bleeding; or previous coagulation disorder or systemic bleeding disease history.
* History of thrombocytopenia or neutropenia.
* History of blood system diseases or liver function abnormalities caused by medication
* Contraindications to ginkgo drugs and a history of known allergies.
* Aphasia, severe hearing or v…