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

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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 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


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

Value
https://center6.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