None listed
Conditions
Interventions
Drug : Kamiguibitang(Kyungbang pharmaceutical.), 1Pk for once. three times a day, 24 weeks, per os.
Placebo(Kyungbang pharmaceutical.), 1Pk for once. three times a day, 24 weeks, per os.
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who was diagnosed with amnestic MCI (aMCI) by a neurologist through the Seoul Neuropsychologic Screening Battery(SNSB) among those who were found not to have dementia through NINCDS-ADRDA (National Institue of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association). - GDS(Global Deterioration Scale) = 3 - CDR (Clinical Dementia Rating) = 0.5 - K-MMSE(Mini-Mental Status Examination)= within normal range 2) Those who have not received cognitive-related medication within the last 2 weeks * cognitive-related medication : Cerebral blood flow improvement agents such as gliatirin and tanamine, and other brain nutrients, which may affect brain cognition. 3) Those who have been stable for the past 2 weeks or more without any change in the drug used for the underlying disease, and who are planned to be stable during this clinical trial. 4) Those who have no problem with communication 5) Those who do not qualify for disqualification related to MRI(magnetic resonance imaging).
Exclusion criteria
Exclusion criteria: 1) Those with brain disorders that cause other neurological symptoms other than cognitive dysfunction 2) Patients with degenerative brain disease such as Parkinson's disease, Huntington's chorea, Down syndrome, and Creutzfeldt-Jakob disease on history and neurological examination 3) Cerebral trauma due to hypoxia such as cerebral trauma and carbon monoxide poisoning, vitamin deficiency, infectious diseases such as neurosyphilis or encephalitis, brain tumor, endocrine metabolic disease, mental retardation 4) If there is evidence of clinically evident cerebrovascular disease, or if there is suspicion of a territorial infarct of cerebral blood vessels due to multiple strokes on MRI(magnetic resonance imaging) 5) Patients with a history of convulsive disease (except for febrile convulsions in childhood) 6) Those with a history of depression or who are currently suffering from depression 7) Those with mental illness or who have behavioral problems requiring psychotropic medication 8) Persons with physical disabilities that cause life threatening and require immediate treatment. 9) Patients with uncontrolled hypertension 10) Patients with Heart or kidney disease 11) Patients with edema 12) Those with gastrointestinal symptoms (anorexia, stomach discomfort, nausea, abdominal pain, diarrhea, etc.) 13) Those who are taking medications that may cause hypokalemia or myopathy. 14) Persons with hypersensitivity to the components of clinical trial medicines 15) Those with possible pregnancy 16) Patients with clinically significant abnormalities in blood chemistry [SGPT(Serum Glutamic Pyruvic Transaminase) / SGOT(Serum Glutamic Oxaloacetic Transaminase)] : more than 2 times the normal upper limit, serum creatinine: 10% of the normal upper limit) 17) Those who participated in other clinical trials within 4 weeks 18) An illiterate participant 19) Other patients who were deemed inadequate by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SNSB(Seoul Neuropsychologic Screening Battery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of brain metabolites, neurotransmitters, cerebral blood flow, amyloid ß(Aß) protein, tau protein, HMGB, SERF 1A, cholesterol derivative | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Bin Yim
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed