UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051091 |
|---|---|
| Receipt number | R000058265 |
| Scientific Title | Validation study of an evaluation method for non-invasive measurement of blood hemoglobin concentration |
| Date of disclosure of the study information | 2023/05/20 |
| Last modified on | 2023/05/17 22:44:04 |
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Basic information
Public title
Test of an evaluation method to measure blood hemoglobin concentration without harming the body
Acronym
Test of an evaluation method for intact measurement of blood hemoglobin concentration
Scientific Title
Validation study of an evaluation method for non-invasive measurement of blood hemoglobin concentration
Scientific Title:Acronym
Validation study of an evaluation method for non-invasive measurement of blood Hb concentration
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate a non-invasive method of measuring blood hemoglobin concentration.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Blood hemoglobin concentration calculated by this measurement method
-Blood hemoglobin concentration by colorimetric method
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female the ages of 25 and 35
Key exclusion criteria
1. Person who has a disease currently treatment.
2. Person who takes medications (antihypertensive, sleeping pills, antiallergic, sedatives, hormones, and other medications for illnesses).
3. Person who has thin (BMI < 18.5) or overweight (BMI > 30.0).
4. Person who has pregnant or possibly pregnant.
5. Person who currently has fever symptoms, rhinitis symptoms, or atopic symptoms.
6. Person who has ever smoked.
7. Person who has external injury to the measurement site (the ring finger of the non-dominant arm).
8. Person who deemed inappropriate by the investigator and study personnel.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Kataoka |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
kataoka.kiyoshi@kao.com
Public contact
Name of contact person
| 1st name | Yoshinao |
| Middle name | |
| Last name | Nagashima |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
Homepage URL
nagashima.yoshinao@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association analysis between this measurement method and the colorimetric method in blood hemoglobin concentration.
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058265
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| Registered date | File name |
| Research case data | |
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