UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010626 |
|---|---|
| Receipt number | R000012426 |
| Scientific Title | Effect of Waon Therapy on Cardio-Vascular Ankle Index |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2024/05/08 13:25:39 |
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Basic information
Public title
Effect of Waon Therapy on Cardio-Vascular Ankle Index
Acronym
Effect of Waon Therapy on Cardio-Vascular Ankle Index
Scientific Title
Effect of Waon Therapy on Cardio-Vascular Ankle Index
Scientific Title:Acronym
Effect of Waon Therapy on Cardio-Vascular Ankle Index
Region
| Japan |
Condition
Condition
Patients who are treated with Waon therapy
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Waon Therapy on Cardio-Vascular Ankle Index
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of Cardio-Vascular Ankle Index
Key secondary outcomes
Changes of inflammatory markers and oxidative stress markers
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
| Device,equipment |
Interventions/Control_1
Waon therapy
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 is treated with Waon therapy
2) Patients who give informed consent
3) Patients aged 20 years or older
Key exclusion criteria
1) Patients with amputated extremity or severe dermal disorders
2) Patients who judged as ineligible by clinical investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
shimakaz@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiology, Juntendo University School of Medicine
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
Juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo Bunkyo-ku Tokyo
Tel
03-3813-3111
chiken@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012426
