UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020224 |
|---|---|
| Receipt number | R000023360 |
| Scientific Title | Study on the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients |
| Date of disclosure of the study information | 2015/12/16 |
| Last modified on | 2018/12/18 13:29:44 |
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Basic information
Public title
Study on the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients
Acronym
Study on the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients
Scientific Title
Study on the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients
Scientific Title:Acronym
Study on the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients
Region
| Japan |
Condition
Condition
Sjogren's synrome
Classification by specialty
| Clinical immunology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of the combination of cepharanthin and low-intensity pulsed ultrasound for Sjogren's syndrome patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of infiltrateon of lymphocytes
Key secondary outcomes
Increase in salivary flow, Improvement of CRP level
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 | Device,equipment |
Interventions/Control_1
Cephalanthin, Low-intensity-pulsed ultrasound
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary Sjogren's syndrome
Key exclusion criteria
Secondary Sjogren's syndrome, Xerostomia due to aging
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Tanaka |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Orthodontics and Dentofacial Orthopedics
Zip code
Address
Kuramoto-cho 3-18-15, Tokushima
TEL
088-633-7357
etanaka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Kawai |
Organization
Tokushima University Graduate School of Oral Sciences
Division name
Department of Orthodontics and Dentofacial Orthopedics
Zip code
Address
Kuramoto-cho 3-18-15, Tokushima
TEL
088-633-7357
Homepage URL
kamo@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics and Dentofacial Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
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
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
| 2015 | Year | 12 | Month | 16 | 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
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023360
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
