UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043173 |
|---|---|
| Receipt number | R000049190 |
| Scientific Title | The Associated Factors to Develop Postherpetic Neuralgia |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/12/22 10:55:03 |
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Basic information
Public title
The Associated Factors to Develop Postherpetic Neuralgia
Acronym
The Associated Factors to Develop Postherpetic Neuralgia
Scientific Title
The Associated Factors to Develop Postherpetic Neuralgia
Scientific Title:Acronym
The Associated Factors to Develop Postherpetic Neuralgia
Region
| Japan |
Condition
Condition
Zoster associated pain. We use the data from the study "The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0"(UMIN000035149)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess the factors associated with developing of Postherpteic Neuralgia. We use the data from the study "The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0"(UMIN000035149).
Basic objectives2
Others
Basic objectives -Others
To assess the factors associated with developing of postherpteic neuralgia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the factors associated with developing of postherpteic neuralgia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients who visited our institution within 1 month from onset of zoster
Key exclusion criteria
The patient who can not answer the Questionnaires, for example, who can not understand Japanese, who has severe dementia or intellectual disability.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Fujiwara |
Organization
Nara medical university
Division name
the department of Anesthesiology
Zip code
6348522
Address
840, Shijocho Kashihara Nara
TEL
+81744298902
higemo1117@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Fujiwara |
Organization
Nara Medical University
Division name
the department of Anesthesiology
Zip code
6348522
Address
840, Shijocho Kashihara Nara
TEL
+81744298902
Homepage URL
higemo1117@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara 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
Nara Medical University Ethics Committee
Address
840, Shijocho Kashihara Nara
Tel
+81744298902
higemo1117@yahoo.co.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
| 2021 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the observational study examined the associated factor to develop postherpetic neuralgia.
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049190
| 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 |
