UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013138 |
|---|---|
| Receipt number | R000015306 |
| Scientific Title | A Clinical Study for arteriosclerosis improvement by percutaneously absorbed lipokine |
| Date of disclosure of the study information | 2014/02/12 |
| Last modified on | 2014/02/12 11:05:56 |
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Basic information
Public title
A Clinical Study for arteriosclerosis improvement by percutaneously absorbed lipokine
Acronym
A Clinical Study for arteriosclerosis improvement by percutaneously absorbed lipokine
Scientific Title
A Clinical Study for arteriosclerosis improvement by percutaneously absorbed lipokine
Scientific Title:Acronym
A Clinical Study for arteriosclerosis improvement by percutaneously absorbed lipokine
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the percutaneous absorption abilities and pharmacokinetics of macadamia nut oil with healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Changes in blood fatty acid content
Flow Mediated Dilation(FMD)
Serum adiponectin concentration
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
| Other |
Interventions/Control_1
20-minute massage with 10 ml of macadamia nut oil
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient who have metabolic syndrome or BMI 25<, obesity
2) Patients who are obtained with the prior written consent.
Key exclusion criteria
1) Patient who have a history of allergic disease.
2) Patient who had an allergic reaction in the patch test.
3) Patient who has the possibility of pregnancy, pregnancy.
4) People who have cognitive disorder (delirium, dementia and so on), schizophrenia or bipolar disorder.
5) Patients judged to be inappropriate for this study from the doctor in charge.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Ito |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
juki@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Sakaue |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
Homepage URL
mikity@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Complementary and Alternative Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Department of Complementary and Alternative 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
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 12 | 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
| 2011 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 12 | Day |
Last modified on
| 2014 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015306
