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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013842
Receipt No. R000016042
Scientific Title A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome.
Date of disclosure of the study information 2014/06/01
Last modified on 2016/11/10

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Basic information
Public title A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome.
Acronym The effect of transcutaneous application of CO2 on post-plio syndrome.
Scientific Title A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome.
Scientific Title:Acronym The effect of transcutaneous application of CO2 on post-plio syndrome.
Region
Japan

Condition
Condition Post-Polio Syndrome
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficiacy and safety of novel transcutaneous application of carbon dioxide in the patients with post-polio syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electromyogram
Visual analog scales for coldness, pain, fatigue and general conditions.
Muscle power
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Transcutaneous application of CO2
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients with muscle weakness in post polio syndrome
2. patients who are 20 years old or older
3. patients who can obtain informed consent with written by themselves or regal representive.
Key exclusion criteria 1.Patients with arteriosclerosis obliterans (Fontaine III-IV)
2.Patients with chronic heart failure (NYHA IV)
3.Possibility of pregnancy
4.Respiratory failure (%VC60% or less)
5. Severe anemia (Hb 7.0 g/dl or less
6.Large skin ulcer or severe skin disorder
7.Researcher's decision of unsuitable
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitada Sakai
Organization Kobe University Graduate School of Medicine
Division name Division of Rehabilitation Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan
TEL 078-382-6826
Email yossie@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitada Sakai
Organization Kobe University Graduate School of Medicine
Division name Division of Rehabilitation Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan
TEL 078-382-6826
Homepage URL
Email yossie@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 06 Month 01 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
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 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
2014 Year 04 Month 30 Day
Last modified on
2016 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016042

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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