UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019824 |
|---|---|
| Receipt number | R000022710 |
| Scientific Title | Randomized double-blind cross-over study for the effect of NKCP on healthy volunteers with stiff shoulders |
| Date of disclosure of the study information | 2015/11/17 |
| Last modified on | 2019/06/25 11:26:05 |
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Basic information
Public title
Randomized double-blind cross-over study for the effect of NKCP on healthy volunteers with stiff shoulders
Acronym
The study of NKCP on healthy volunteers with stiff shoulders
Scientific Title
Randomized double-blind cross-over study for the effect of NKCP on healthy volunteers with stiff shoulders
Scientific Title:Acronym
The study of NKCP on healthy volunteers with stiff shoulders
Region
| Japan |
Condition
Condition
Healthy volunteers with stiff shoulders
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to determine whether NKCP, purified from Bacillus natto, improves stiff shoulders and shoulder pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Stiff shoulder and shoulder pain were evaluated using the pain visual analog scale (VAS).
2. Shoulder joint flexibility was evaluated using Shoulder 36 Ver.1.3.
3. Shoulder stiffness was measured by muscular tissue hardness meter.
These experiments were performed at preinitiation period and after 4, 8, and 12 weeks.
Key secondary outcomes
Blood pressure, plus rate
The measurement of swelling of a foot
The measurement of blood flow and thermographic analysis around shoulder
The measurement of tiredness
These experiments were performed at preinitiation period and after 4, 8, and 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention, group A
NKCP 250 mg/day for 4 weeks
A washout period for 4 weeks
placebo for 4 weeks
Interventions/Control_2
Intervention, group B
placebo for 4 weeks
A washout period for 4 weeks
NKCP 250 mg/day 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The healthy volunteers with stiff shoulder
Key exclusion criteria
1) The person with underlying disease
2) Pregnancy and nursing
3) Cognitive impairment
4) The person who uses the supplement which influence stiff shoulder
5) The person who participates in other clinical trials at the time of this study entry
6) etc
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Morimoto |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
Address
52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL
054-264-5763
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Sunagawa |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
Address
52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL
054-264-5772
Homepage URL
nkcp.test@gmail.com
Sponsor or person
Institute
University of Shizuoka
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
Seirei Health Support-Center Shizuoka
SBS Shizuoka Health Promotion Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
静岡県立大学
聖隷健康サポートセンターShizuoka
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1248/bpb.b17-00780
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
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 04 | 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
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
