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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034436
Receipt No. 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

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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
Institute Kirin Company, Limited
Institute
Department

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
URL(English) https://upload.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


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