UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028498 |
|---|---|
| Receipt number | R000032614 |
| Scientific Title | Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2018/03/01 08:33:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness
Acronym
Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness
Scientific Title
Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness
Scientific Title:Acronym
Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness
Region
| Japan |
Condition
Condition
Shoulder stiffness, lower back pain, and poor blood circulatio
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of bedding that contains plant-based carbon fiber on nutritional requirement, muscle hardness, and blood circulation. To conduct a study on a commercially available product to examine effects thereof on actual use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Nutritional requirement through analysis of expired gas
Muscle hardness
Blood flow rate
Survey on subjective symptoms
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
2-week use of the test product
Interventions/Control_2
2-week use of the placebo product
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1.Age: 30 and over, below 80
2.Sex: Female
3.Subjective symptoms of shoulder stiffness, lower back pain, and poor blood circulation.
4.Persons who voluntarily agree to participate in this study.
5.Persons with a habit of sleeping on a futon or bed alone.
Key exclusion criteria
1.Currently seeing a doctor in treatment of or previous history of shoulder stiffness, lower back pain, and/or poor blood circulation
2.Regular intake of medication or supplements for shoulder stiffness, lower back pain, and/or poor blood circulation
3.Currently in treatment with medication
4.Presence or previous history of a severe disorder(s) such as diabetes, a circulatory disease, a hepatic disease, a renal disease, or a cardiac disease
5.Currently seeing a doctor in treatment of or previous history of Intervertebral disk displacement or rheumatism
6.BMI of below 18.5, 25.0 and higher
7.Working on night shift or with alternative work schedule
8.Current participation in another clinical trial (including studies on food products and cosmetics)
9.Presence or previous history of psychiatric visits for depression, a sleep disorder, etc.
10.Nursing or pregnant, or desired to become pregnant during the study
11.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
ORGAHEXA Inc
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 10 | 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
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 25 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 25 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032614
