UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045888 |
|---|---|
| Receipt number | R000052388 |
| Scientific Title | Efficacy of new carbon dioxide paste on human gastrocnemius muscle. |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2022/04/28 09:46:20 |
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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
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
akisue@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052388
