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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2018/01/02
    • Registered Date : 2019/01/10
    • Last Updated Date : 2018/11/16
Background Information
1.Background  
CRIS Registration Number KCT0003419 
Unique Protocol ID DJDS NP _16_08 
Public/Brief Title The Study of Reliability and Validity of Pattern Identifications Tool for Cognitive Disorders(PIT-C) 
Scientific Title The Study of Reliability and Validity of Pattern Identifications Tool for Cognitive Disorders(PIT-C)  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number DJDSKH-17-BM-29 
Approval Date 2018-08-31 
Institutional Review Board  
- Name Daejeon University, Dunsan Medical Center, Institutional Review Board  
- Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea 
- Telephone 042-470-9488 
Data Monitoring Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name In chul Jung 
- Title Professor 
- Telephone +82-42-470-9129 
- Affiliation Daejeon University 
- Address Daejeon Dong-gu Daehaglo 62 
Contact Person for Public Queries
- Name Jiyoon Lee 
- Title Resident 
- Telephone +82-42-470-9561 
- Affiliation Dunsan Korean Medicine Hospital of Daejeon University 
- Address Daedeogdaelo 176beongil 75, Seo-gu, Daejeon, Korea 
Contact Person for Updating Information
- Name Jiyoon Lee 
- Title Resident 
- Telephone +82-42-470-9561 
- Affiliation Dunsan Korean Medicine Hospital of Daejeon University 
- Address Daedeogdaelo 176beongil 75, Seo-gu, Daejeon, Korea 
Status
4. Status Status  
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-10-17 , Actual
Target Number of Participant 60
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1 
- Name of Study Site Dunsan Korean Medicine Hospital of Daejeon University 
- Recruitment Status Recruiting  
- Date of First Enrollment 2018-10-17 , Actual
Recruitment Status by Participating Study Site 2 
- Name of Study Site Wonkwang University Sanbon Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2018-10-17 , Actual
Recruitment Status by Participating Study Site 3 
- Name of Study Site Wonkwang University Oriental Medical Hospital, Jeonju 
- Recruitment Status Recruiting  
- Date of First Enrollment 2018-10-17 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Ministry of Health & Welfare 
- Organization Type Government  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Dunsan Korean Medicine Hospital of Daejeon University 
- Organization Type Medical Institute  
Sponsor Organization 2 
- Organization Name Wonkwang University Sanbon Hospital 
- Organization Type Medical Institute  
Sponsor Organization 3 
- Organization Name Wonkwang University Oriental Medical Hospital, Jeonju 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary This study is a clinical study to evaluate the reliability and validity of the cognitive impairment assessment tool.
Early diagnosis and treatment of dementia are particularly important diseases because dementia has not yet been shown to be a fundamental therapeutic agent and has been reported to delay the progress of the disease.
In Oriental medicine, there is no disease name that accurately responds to modern dementia disease. However, the characteristic memory impairment and cognitive dysfunction in dementia, psychological behavior problems, dementia, dementia, amnesia, epilepsy, hunger, )) And so on.
Based on the literature review and the expert opinion survey, the self - diagnosis scale of the dementia diagnosed by four types of divergence such as 气虛, 虚虛, 火 热 and 痰) is established, Reliability evaluation Clinical studies were conducted to confirm validity and reliability.
However, an amendment was made to reflect the results of the clinical study and additional clinical studies were conducted to apply it to mild cognitive impairment other than dementia.
The evaluators of this study should be two study doctors A and B who have studied and practiced enough to understand the purpose of the research evaluation tool, examination and scoring method. In Screening and Visit 1, after the applicant A judges the appropriateness of the selection criteria and the exclusion criterion for the applicants, the oriental medical practitioners A and B respectively implement the evaluation tool for cognitive impairment. The visit 2 is performed within 7 ± 3 days after screening and visit 1, and the oriental doctor A re-examines the cognitive-dysfunctional assessment tool, the diagnostic tool for the diagnosis of dementia, and the Mini-Mental State Examination-Dementia Screening. The subjects are also screened, pulse test, body composition test, Electroencephalography, and brain oxygen saturation test.  
Study Design 정보
8. Study Design  
Study Type Observational Study 
Observational Study Model Case-only 
Time Perspective Prospective  
Target Number of Participant 60
Cohort/Group Number
Cohort/
Group 1
Cohort/
Group Label
Observation group 
Group Description In Screening and Visit 1, after the applicant A judges the appropriateness of the selection criteria and the exclusion criterion for the applicants, the oriental medical practitioners A and B respectively implement the evaluation tool for cognitive impairment. The visit 2 is performed within 7±3 days after screening and visit 1, and the doctor A examines the cognitive dysfunction evaluation tool and the dementia And the Mini-Mental State Examination-Dementia Screening. The subjects are also screened, pulse test, body composition test, Electroencephalography, and Brain oxygen saturation test. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Subject Eligibility Information
9. Subject  
Study Population Description Male and female adults aged 45 to under 85 years who visited for cognitive impairment  
Sampling Method This study uses non-random sampling method which is one of the widely used sampling methods in clinical studies.
We select all the subjects who satisfy the selection criteria at a specific time interval or patients, and draw a random sample of the participants voluntarily participating in the experiment.
Probabilistic sampling is a time- and cost-intensive method of collecting the entire list of probabilistic probes from the sampling list itself in order to ensure that all members of the population are equally selected. we don't use that method because it is not suitable for extraction method.  
Condition(s)/Problem(s) * Mental and behavioral disorders
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 45 Year ~ 84 Year
Description 1) Aged 45 to under 85 old, male and female adults
2) Those diagnosed with major or mild neurological dysfunction according to the DSM-5 standard
3) Clinical Dementia Rating 0.5 or 1 person
4) Korean version of the Montreal Cognitive Assessment Below 22 points
5) The caregiver or caregiver who cares for the patient or the patient understands the contents of the questionnaire.
A person
6) If the patient or his / her legal representative voluntarily agrees to the clinical study consent in writing  
Exclusion Criteria 1) In cases of dementia due to systemic diseases such as endocrine, infection (eg hypothyroidism, thiamin, rain Thymine B12 deficiency, neurosyphilis, human immunodeficiency virus, encephalitis, etc.)
2) Psychiatric disorders diagnosed by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition: schizophrenia, delusional disorder, bipolar disorder Those with a history of major psychiatric disorders such as mental or substance abuse disorders
3) Those with a seriously unstable medical condition (such as clinical laboratory tests, vital signs, etc. By the judgment of the doctor in charge)
4) Malignant tumor patients who were not cured
5) History of head injury that causes loss of consciousness for more than 1 hour
6) History of traumatic brain hemorrhage, brain tumor, subarachnoid hemorrhage
7) Those who are at risk of suicide
8) If the applicant or legal representative does not understand the consent, Occation
9) Those who are not eligible to participate in this clinical study at the discretion of other researchers
10) If you participated in other clinical studies within the first month of the study or during the test period If you plan to participate in other clinical studies  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome Pattern identification tool for Cognitive Disorders 
- Timepoint day 0, day 7 
Secondary Outcome(s) 1 
- Outcome Korean diagnostic tool of dementia 
- Timepoint day 7 
Secondary Outcome(s) 2 
- Outcome Pattern identification inventory of Cold, Heat, Deficiency and Excess 
- Timepoint day 7 
Secondary Outcome(s) 3 
- Outcome Korean Version of Montreal Cognitive Assessment 
- Timepoint Screnning 
Secondary Outcome(s) 4 
- Outcome Korean Version of Expanded Clinical Dementia Rating 
- Timepoint Screnning 
Secondary Outcome(s) 5 
- Outcome Neuropsychiatric Inventory–Questionnaire 
- Timepoint day 7 
Secondary Outcome(s) 6 
- Outcome Korean Instrumental Activities of Daily Living 
- Timepoint day 7 
Secondary Outcome(s) 7 
- Outcome Mini-Mental State Examination-Dementia Screening 
- Timepoint day 7 
Secondary Outcome(s) 8 
- Outcome Tongue Diagnosis Examination 
- Timepoint day 7 
Secondary Outcome(s) 9 
- Outcome Pulse Diagnosis Examination 
- Timepoint day 7 
Secondary Outcome(s) 10 
- Outcome Bioelectrical Impedance Analyzer 
- Timepoint day 7 
Secondary Outcome(s) 11 
- Outcome Electroencephalography 
- Timepoint day 7 
Secondary Outcome(s) 12 
- Outcome Brain oxygen saturation test 
- Timepoint day 7 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration