UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031114 |
|---|---|
| Receipt number | R000035532 |
| Scientific Title | Effects of NKCP on the improvement of Bloodstream |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2020/08/05 12:38:50 |
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Basic information
Public title
Effects of NKCP on the improvement of Bloodstream
Acronym
Effects of NKCP on the improvement of Bloodstream
Scientific Title
Effects of NKCP on the improvement of Bloodstream
Scientific Title:Acronym
Effects of NKCP on the improvement of Bloodstream
Region
| Japan |
Condition
Condition
Healthy volunteers with cold sensitivity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effect of a NKCP, purified from Bacillus natto, on the improvement of Bloodstream.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bloodstream, pulsation (Week 0, Week 4, Week 8)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
NKCP 250 mg/day for 4 weeks
A washout period for 4 weeks
Interventions/Control_2
Placebo for 4 weeks
A washout period for 4 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 30-70 years
2) Individuals who are cold sensitivity
3) Individuals whose written informed consent has been obtained
4) Individuals judged appropriate for the study by the principal
Key exclusion criteria
1) Individuals who receives a drug influencing blood coagulation system
2) Individuals who has a cardiovascular disease, the cerebro-vascular disease past or under treatment
3) Individuals who has a diagnosis of intractable peripheral circulatory disease such as Raynaud's disease
4) Individuals who has a disease judged to affect the examination results
5) Individuals who are sensitive to a food containing test product or other foods, and medical products
6) Individuals who have a habit of smoking
7) Individuals that the change of the lifestyle is planned during a study time (a night-work, a long-term trip, the transfer)
8) Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period
9) Individuals who participated in other clinical studies in the past three months
10) Individuals who are or are possibly pregnant, or are lactating
11) etc
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazumitsu |
| Middle name | |
| Last name | Ohya |
Organization
KSP Clinic
Division name
President
Zip code
2130012
Address
3-2-1, Sakato, Takatsu-ku, Kanagawa
TEL
054-282-1109
dokku@sbs-smc.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Inoue |
Organization
Laboratory of Cell Applied Technologies, Co
Division name
Director
Zip code
2168512
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8512 Japan
TEL
044-979-1622
Homepage URL
info@l-cat.co.jp
Sponsor or person
Institute
Laboratory of Cell Applied Technologies, Co
Institute
Department
Personal name
Funding Source
Organization
Daiwa Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koganeihashi Sakura Clinic Clinical Trial Review Committee
Address
2-11-25 Sakuramachi, Koganei-shi, Tokyo
Tel
042-382-5252
chiken@kb-clinic.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
KSPクリニック 溝の口健康管理センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035532
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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