UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039168 |
|---|---|
| Receipt number | R000044672 |
| Scientific Title | The pilot study on evaluation of EPA+DHA therapy with Endo-PAT |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2020/01/15 20:13:05 |
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Basic information
Public title
The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Acronym
The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Scientific Title
The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Scientific Title:Acronym
The pilot study on evaluation of EPA+DHA therapy with Endo-PAT
Region
| Japan |
Condition
Condition
Cases with reduced vascular endothelial function
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of administration of EPA + DHA on patients with decreased endothelial function by Endo-PAT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in RHI value 12 weeks after starting EPA + DHA administration by Endo-PAT test
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
Administer EPA + DHA (Rotriga) 4g / day for 12 weeks.
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) With dyslipidemia, indicated for taking EPA + DHA.
2) RHI value by Endo-PAT test is less than 1.67.
3) Age at the time of consent is 20 years or older.
4) Informed consent has been obtained from the person in question regarding participation in the research.
Key exclusion criteria
Does not meet eligibility criteria
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tobita |
Organization
Shimane University School of Medicine
Division name
Hepatology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane
TEL
0853-20-2190
ht1020@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Tobita |
| Middle name | |
| Last name | Hiroshi |
Organization
Shimane University School of Medicine
Division name
Hepatology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane
TEL
0853-20-2190
Homepage URL
ht1020@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine
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
Shimane University School of Medicine
Address
89-1 Enya-cho, Izumo-shi, Shimane
Tel
0853-20-2190
ht1020@med.shimane-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
| 2020 | Year | 01 | Month | 15 | 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
10
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
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044672
