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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028498
Receipt No. 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

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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
Email 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
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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