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Safety and efficacy of Jujadokseo-hwan for Memory Deficit(amnesia) in Mild Neurocognitive Disorder : A Randomized, Double-blind, Placebo-controlled, parallel-group, Multicenter clinical trial

Safety and efficacy of Jujadokseo-hwan for Memory Deficit(amnesia) in Mild Neurocognitive Disorder : A protocol for Randomized, Double-blind, Placebo-controlled, parallel-group, Multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0003570
Enrollment
80
Registered
2019-02-28
Start date
2018-10-19
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The name of the investigational agent is Jujadokseo-hwan, a black pill, and oral administration. A pill has a 100mg capacity, and consists of Poria cocos Wolf, Polygalae Radix, Ginseng Radix,

Sponsors

Dunsan Korean Medicine Hospital of Daejeon University
Lead Sponsor
Wonkwang University Sanbon Hospital
Collaborator
Wonkwang University Oriental Medical Hospital, Jeonju
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 45 to over 85 2) A person diagnosed with a mild cognitive impairment according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 3) Korean Version of Expanded Clinical Dementia Rating  0.5 and Global Deterioration Scale 2-3 4) Korean Version of Montreal Cognitive Assessment  Below 22 points 5) There is no limit to the instrumental ability to perform everyday activities (less than Korean Instrumental Activities of Daily Living 0.43) 6) Education level of more than 6 years 7) The person who is the subject of the test or the person who has voluntarily agreed to the clinical trial consent in writing

Exclusion criteria

Exclusion criteria: 1) Alzheimer's disease, vascular dementia, Parkinson's disease, Huntington's disease, hydrocephalus, etc. 2) general medical conditions causing dementia, such as hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, hyperkalemia, neurosyphilis, human immunodeficiency virus, etc. 3) The short-form elderly depression scale score is 10 or more 4) Schizophrenia Mental diagnosed by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, such as delusional disorder, bipolar disorder, alcohol or substance abuse disorders if the current history of major psychiatric disorders 5) If there is a history or history of neurological disorders such as epilepsy, local brain damage, head trauma, stroke 6) Currently taking anti-dementia drugs or hormones such as acetylcholinesterase inhibitors 7) with gastrointestinal, endocrine, and cardiovascular disease not controlled by diet or medication 8) In case of general unstable medical condition (according to the standard work instructions, the research doctor judges based on the results of vital signs, clinical pathology, electrocardiogram, chest radiography, etc.) 9) Patients with diabetes or insulin-dependent diabetes mellitus not controlled by hypoglycemic agents 10) Patients with hypertension whose systolic blood pressure is 160 mmHg and whose diastolic blood pressure exceeds 95 mmHg 11) Clinically significant liver disease or serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase If the upper limit of the reference value is more than twice 12) In patients with chronic renal failure or serum creatinine, 13) Pregnant, lactating women or women who do not use appropriate methods of contraception 14) Those who received medical treatment for mild cognitive impairment within 1 month before the start of the study 15) Those who participated in other clinical trials with interventions within one month before starting the study 16) If the subject is found to be inappropriate for participation in clinical trials due to other reasons

Design outcomes

Primary

MeasureTime frame
Seoul Verbal Learning Test

Secondary

MeasureTime frame
Digit Span Test;The Korean-Boston Naming Test;Calculation;Rey Complex Figure Test;Controlled Oral Word Association Test;Korean-Color Word Stroop Test;Digit Symbol Coding;Korean-Trail Making Test for the Elderly;Korean Version of Montreal Cognitive Assessment;Mini-Mental State Examination-Dementia Screening;EuroQol-5 dimension;Korean Version of Quality of Life-Alzheimer's Disease;Pattern Identifications Tool for Cognitive Disorders;Measuring Benefits and Costs;Tongue Diagnosis Examination ;Pulse Diagnosis Examination ;Bioelectrical Impedance Analyzer;Electroencephalography ;functional Near-infrared spectroscopy;Korean Version of Expanded Clinical Dementia Rating;Global Deterioration Scale;Short-form Geriatric Depression Scale;blind test

Countries

Korea, Republic of

Contacts

Public ContactJiyoon Lee

Dunsan Korean Medicine Hospital of Daejeon University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 19, 2026