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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016621
Receipt No. 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

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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
Email 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
Email yk-katayama@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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