UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an influence of continued use of plant-based carbon fiber on muscle stiffness
Title of the study (Brief title)	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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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