The Efficacy of Kami Guibi-tang for Improving Cognitive Function in Mild Cognitive Impairment Patients : A Randomized, Double-blind, Placebo-controlled Trial
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0007039
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
1. Those aged 55-90 who were diagnosed with amnestic mild cognitive impairment (aMCI) by a neurologist through the Seoul Neuropsychologic Screening Battery(SNSB) based on the diagnostic criteria for MCI suggested bt Albert et al.
- GDS(Global Deterioration Scale) = 3
- CDR (Clinical Dementia Rating) = 0.5
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.
- Also excludes taking dementia treatments such as donepezil, rivastigmine, and gallantamine.
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).
1. Those who diagnosed with dementia by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association)
2. Those who diagnosed as vascular cognitive impairment by NINDS-AIREN
3. Those with brain disorders that cause other neurological symptoms other than cognitive dysfunction
4. Patients with degenerative brain disease such as Parkinson's disease, Huntington's chorea, Down syndrome, and Creutzfeldt-Jakob disease on history and neurological examination
5. 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
6. 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)
7. Patients with a history of convulsive disease (except for febrile convulsions in childhood)
8. Those with a history of depression or who are currently suffering from depression
9. Those with mental illness or who have behavioral problems requiring psychotropic medication
10. Those who have substance abuse (drug addiction, alcoholism, etc.).
11. Persons with physical disabilities that cause life threatening and require immediate treatment.
12. Patients with uncontrolled hypertension
13. Patients with Heart or kidney disease
14. Patients with edema
15. Those with gastrointestinal symptoms (anorexia, stomach discomfort, nausea, abdominal pain, diarrhea, etc.)
16. Those who are taking medications that may cause hypokalemia or myopathy.
17. Persons with hypersensitivity to the components of clinical trial medicines
18. Those with possible pregnancy
19. Patients with clinically significant abnormalities in blood chemistry (SGPT/ SGOT : more than 2 times the normal upper limit, serum creatinine: 10% of the normal upper limit)
20. Those who participated in other clinical trials within 4 weeks(or Longer than 5 times the half-life of clinical trial drugs).
21. An illiterate participant
22. Other patients who were deemed inadequate by the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total SNSB(Seoul Neuropsychologic Screening Battery)-D Score
- Secondary Outcome Measures
Name Time Method SNSB(Seoul Neuropsychologic Screening Battery) Score;CDR-GS, GDS;Barthel ADL, K-IADL;MRI measures(Gray matter volume, Face-Name Association Task, N-back Working Memory Task, Resting-state Memory Network);amyloid ß(1-40) amyloid ß(1-42) protein