UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007251 |
|---|---|
| Receipt number | R000008549 |
| Scientific Title | The effect of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria-randomized study- |
| Date of disclosure of the study information | 2012/02/08 |
| Last modified on | 2018/08/14 09:35:45 |
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Basic information
Public title
The effect of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria-randomized study-
Acronym
The effect of "JUMIHAIDOKUTO" on chronic urticaria
Scientific Title
The effect of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria-randomized study-
Scientific Title:Acronym
The effect of "JUMIHAIDOKUTO" on chronic urticaria
Region
| Japan |
Condition
Condition
chronic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria by randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) severity
2) QoL (Skindex-16)
3) Itch VAS
4) medical interview
5) recurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
JUMIHAIDOKUTO+antihistamines (internventions)
Interventions/Control_2
antihistamines (control)
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic urticaria suffered for over 4 weeks.
2) The symptom is difficult to treat with standard therapy with antihistamines.
3) patients whose QoL and daily activity was impaired by its symptom.
Key exclusion criteria
1) decline in physical strength
2) treated with over-dose of antihistamines
3) treated with other herbal medicine
4) treated with systemic steroid
5) with the exception of chorinergic urticaria, cold urticaria, mechanical urticaria and solar urticaria.
6) aldosteronism
7) sever heart failure
8) pregnant female
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hiROYUKI MUROTA |
Organization
Osaka university
Division name
Dept. of dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka univeristy
Division name
dermatology
Zip code
Address
2-2, yamadaoka, suita
TEL
Homepage URL
Sponsor or person
Institute
Osaka university, dept. of dermatology
Institute
Department
Personal name
Funding Source
Organization
Osaka university, dermatology
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
| 2012 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs11655-017-2950-6
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
| 2012 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008549
| 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 |
