UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016621 |
|---|---|
| Receipt number | R000019277 |
| Scientific Title | Effects of Shin'iseihaito in asthma patients with upper airway disease |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2015/04/10 15:55:30 |
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Basic information
Public title
Effects of Shin'iseihaito in asthma patients with upper airway disease
Acronym
Effects of Shin'iseihaito in asthma patients with upper airway disease
Scientific Title
Effects of Shin'iseihaito in asthma patients with upper airway disease
Scientific Title:Acronym
Effects of Shin'iseihaito in asthma patients with upper airway disease
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaliate the effect of Shin'iseihaito to asthma control in asthma patients with upper airway disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of ACT score 12 weeks after the introduction of Shin'iseihaito.
Key secondary outcomes
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 |
Interventions/Control_1
Shin'iseihaito(2.5g/package) 3 packages a day for 12weeks
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among outpatients of bronchial asthma, all of the following criteria was required for enrollment.
(1)age 15 years-old or more
(2)less than 24 points of ACT score
(3)with upper airway deisease
Key exclusion criteria
(1) hypersensitivity of the harbal medicine included in Shin'iseihaito.
(2) interstitial pneumonia
(3) Liver dysfunction; more than 2.0mg/dl of T-Bil or more than 100IU/l of transaminase.
(4) treated with systemic steroid or anti-IgE antibody or the harbal medicine included in Shin'iseihaito.
(5) pregnant or nursing or planning of pregnancy.
(6) the change of medication or surgical treatment are scheduled during study period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Katayama |
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
06-6312-1221
yk-katayama@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Katayama |
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
06-6312-1221
Homepage URL
yk-katayama@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
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 | 02 | Month | 25 | 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
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 17 | 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 | 02 | Month | 24 | Day |
Last modified on
| 2015 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019277
| 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 |
