UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034436
Receipt number R000039264
Scientific Title Evaluation of the efficacy of icing treatment of carbon dioxide-rich ice
Date of disclosure of the study information 2019/10/15
Last modified on 2018/10/10 14:18:22

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Basic information

Public title

Evaluation of the efficacy of icing treatment of carbon dioxide-rich ice

Acronym

Evaluation of the efficacy of icing treatment of carbon dioxide-rich ice

Scientific Title

Evaluation of the efficacy of icing treatment of carbon dioxide-rich ice

Scientific Title:Acronym

Evaluation of the efficacy of icing treatment of carbon dioxide-rich ice

Region

Japan


Condition

Condition

No

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of icing treatment of carbon dioxide-rich ice on muscle condition

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle hardness, Muscle strength, Muscle activity, Voluntary activation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

After exercise, the triceps surae muscle of a participant is treated by 15.0 g of ices that contains large amounts of carbon dioxide for 10 minutes.

Interventions/Control_2

After exercise, the triceps surae muscle of a participant is treated by 15.0 g of ices that contains no carbon dioxide for 10 minutes.

Interventions/Control_3

After exercise, a participant is untreated.

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

35 years-old >=

Gender

Male

Key inclusion criteria

(1) Male subjects aged 20-35 years old who give written informed consent
(2) Give written informed consent after receiving sufficient explanation of the study purpose and details, thoroughly understand the study, and of their own free decide to participate

Key exclusion criteria

(1) Have a disease and/or previous history of heart disease
(2) Have cold urticarial
(3) Are not functionally independent in daily life and cannot perform physical test.
(4) Are participating in other clinical studies on medicine or cosmetics
(5) Could change their life style during the study, e.g. changing their sleeping time, food, exercise.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryota Akagi

Organization

Shibaura Institute of Technology

Division name

Department of Bioscience and Engineering, College of Systems Engineering and Science

Zip code


Address

307, Fukasaku, Minuma-ku, Saitama-shi, Japan

TEL

048-720-6020

Email

rakagi12@sic.shibaura-it.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryota Akagi

Organization

Shibaura Institute of Technology

Division name

Department of Bioscience and Engineering, College of Systems Engineering and Science

Zip code


Address

307, Fukasaku, Minuma-ku, Saitama-shi, Japan

TEL

048-720-6020

Homepage URL


Email

rakagi12@sic.shibaura-it.ac.jp


Sponsor or person

Institute

Kirin Company, Limited

Institute

Department

Personal name



Funding Source

Organization

Kirin Company, Limited

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

学校法人 芝浦工業大学(埼玉県)/ Shibaura Institute of Technology (Saitama)


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 15 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

Preinitiation

Date of protocol fixation

2018 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 10 Day

Last modified on

2018 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039264


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name