UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030662
Receipt No. R000035007
Scientific Title Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste for healthy subjects
Date of disclosure of the study information 2019/01/01
Last modified on 2018/08/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste for healthy subjects
Acronym Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste
Scientific Title Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste for healthy subjects
Scientific Title:Acronym Exploratory clinical trials evaluating the effectiveness and safety of carbon dioxide paste
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Oral surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of improvement of blood flow by carbon dioxide paste application in healthy subjects
Confirmation of safety by carbon dioxide paste application in healthy subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of blood flow by carbon dioxide paste application in healthy subjects
Safety by carbon dioxide paste application in healthy subjects
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
Medicine
Interventions/Control_1 Application of carbon dioxide paste

Apply carbon dioxide paste once on the skin of the lower leg or cervix for 20 minutes. Apply evenly using the fingers as the application method.
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 who are over 20 years of age at the time of consent acquisition
2) Gender: No prejudice
3) Patients who got document consent by their own voluntary intention
Key exclusion criteria 1) Patients with drug hypersensitivity such as allergies
2) Peripheral arterial disease, those with ischemia (Fontaine 3-4)
3) Persons with heart failure (NYHA 4)
4) Persons who are pregnant or may be
5) Persons who have severe respiratory illness
6) Patients who are difficult to apply paste such as large skin ulcers or marked skin diseases
7) Patients who are deemed inappropriate by researchers or doctors
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takumi Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-6213
Email hasetaku@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-6213
Homepage URL
Email hasetaku@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2019 Year 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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
2018 Year 01 Month 02 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.