UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016258 |
|---|---|
| Receipt number | R000016403 |
| Scientific Title | Clinical study of the effectiveness of Saireito on the postoperative edema after blepharoptosis surgery |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2018/07/23 13:57:38 |
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Basic information
Public title
Clinical study of the effectiveness of Saireito on the postoperative edema after blepharoptosis surgery
Acronym
Clinical study of the effectiveness of Saireito on the postoperative edema
Scientific Title
Clinical study of the effectiveness of Saireito on the postoperative edema after blepharoptosis surgery
Scientific Title:Acronym
Clinical study of the effectiveness of Saireito on the postoperative edema
Region
| Japan |
Condition
Condition
blepharoptosis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of of Saireito on the postoperative edema after blepharoptosis surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The degree of postoperative edema 1 week after blepharoptosis surgery
Key secondary outcomes
The degree of postoperative edema 2,4 and 8 weeks after blepharoptosis surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Saireito (EK-114, Kracie Pharma, Ltd., Tokyo, Japan) at 8.1g/day is administered for 8 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older scheduled for surgery
Key exclusion criteria
*Have herbal remedy orally within 2weeks before surgery
*Have any of the following systemic diseases:
1.Requiring continued use of oral corticosteroid therapy (>5 mg/day prednisolone equivalent) or immune-suppressing drug
2.malignant tumor
3.hepatuc failure or renal failure
*6. Other patients judged by the investigator to be inappropriate as a subject of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kusumoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka,
TEL
072-804-0101
prs@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Morimoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
http://www.kmu.ac.jp/hirakata/
morimotn@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
関西医科大学附属枚方病院及び関西医科大学附属滝井病院形成外科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016403
