UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of new carbon dioxide paste on human gastrocnemius muscle.
Acronym	Efficacy of new carbon dioxide paste on human calf muscle.
Scientific Title	Efficacy of new carbon dioxide paste on human gastrocnemius muscle.
Scientific Title:Acronym	Efficacy of new carbon dioxide paste on human gastrocnemius muscle.
Region	Japan

Condition
Condition	muscle injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of new carbon dioxide paste on human gastrocnemius muscle.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle thickness and elasticity by ultrasound sonography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Application of new carbon dioxide paste (20 minutes/day) on the posterior aspect in the calf for one week
Interventions/Control_2	No intervention in the contralateral side
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	18 years-old <=
Age-upper limit	35 years-old >
Gender	Male and Female
Key inclusion criteria	healthy subject
Key exclusion criteria	(1)The person who uses a pain-killer, muscle relaxant, a compress. (2)Person with the pregnancy or its possibility. (3)The person with chronic ache or history of trauma in the calf. (4)The person who underwent a surgery in the lower extremity within three months. (5)The person who may have rashes by contact with liniment and cosmetics. (6)The person who is judged to be ineligible for this intervention by the doctor.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Akisue
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Rehabilitation Science
Zip code	6540142
Address	7-10-2 Tomoga-oka, Suma-ku, Kobe
TEL	0787964596
Email	akisue@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Akisue
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Rehabilitation Science
Zip code	6540142
Address	7-10-2 Tomoga-oka, Suma-ku, Kobe
TEL	0787964596
Homepage URL
Email	akisue@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Kobe University Graduate School of Health Sciences
Address	7-10-2 Tomoga-oka, Suma-ku, Kobe
Tel	0787964502
Email	syomu2@ams.kobe-u.ac.jp

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	2021 Year 10 Month 29 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	2021 Year 08 Month 18 Day
Date of IRB	2021 Year 09 Month 30 Day
Anticipated trial start date	2021 Year 10 Month 29 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 27 Day
Last modified on	2022 Year 04 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052388