UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030512 |
|---|---|
| Receipt number | R000034830 |
| Scientific Title | Effect of Tokito,a traditional Japanese herbal medicine,for postherpetic neuralgia on the dermatome of thoracic nerves. |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2017/12/21 23:36:48 |
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Basic information
Public title
Effect of Tokito,a traditional Japanese herbal medicine,for postherpetic neuralgia on the dermatome of thoracic nerves.
Acronym
Effect of Tokito for thoracoabdominal PHN.
Scientific Title
Effect of Tokito,a traditional Japanese herbal medicine,for postherpetic neuralgia on the dermatome of thoracic nerves.
Scientific Title:Acronym
Effect of Tokito for thoracoabdominal PHN.
Region
| Japan |
Condition
Condition
Postherpetic neuralgia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the outcomes of Tokito for PHN on the dermatome of thoracic nerves.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of pain Visual analog scale
first medical examination,2weeks later,4 weeks later,8weeks later
Key secondary outcomes
Patient satisfaction score
Change of QOL score
Change of surface temperature withThermography
Change of frequency and amount of other treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tokito7.5mg/day, for 2 or 4weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The intractable postherpetic neuralgia patient after at least 3 months' duration who accept sufficient analgetic effect by neither medication nor other treatment
2)The patient who was able to get the consent by the document to this research
Key exclusion criteria
1)The patient from whom consent is not obtained by this research
2)The patient who judged that other doctors were inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
South 1 West 16 Chu-o-ku Sapporo,Hokkaido
TEL
0116112111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Orimo |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
South 1 West 16 Chu-o-ku Sapporo,Hokkaido
TEL
011-611-2111
Homepage URL
ka_o_oriori@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 21 | 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
| 2017 | Year | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034830
| 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 |
