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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033286
Receipt No. R000037952
Scientific Title A study of the effect of syoseiryuto on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)
Date of disclosure of the study information 2018/07/05
Last modified on 2019/03/29

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Basic information
Public title A study of the effect of syoseiryuto on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)
Acronym A study of the effect of syoseiryuto on Japanese cedar pollinosis
Scientific Title A study of the effect of syoseiryuto on Japanese cedar pollinosis (randomized, placebo-controlled, double-blind study using the envionmental challenge chamber)
Scientific Title:Acronym A study of the effect of syoseiryuto on Japanese cedar pollinosis
Region
Japan

Condition
Condition Japnese cedar pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To crarify whether 2 week intake of shoseiryuto suppress the nasal symptoms induced in the environmental challernge chamber.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total nasal symptoms induced in the environmental challernge chamber after intake of the intervention drug for 2 weeks.
Key secondary outcomes Association between "syo" and effect of the Shoseiryuto

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intake of shoseiryuto for 2 weeks
Interventions/Control_2 Intake of placebo for 2 weeks
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who have medical history of cedar pollinosis for more than 2 years.
2)Patients who do not have nasal symtoms induced by any allergen and requier any drug treatment out of Japanese cedar pollen scattering season.
3)Positive specific IgE to cedar pollen allergen(>=class2)
4)Patients who develop more than moderate symptoms by a pollen exposure for 3 hours
Key exclusion criteria 1) Allergy of intervention drug
2) Patients who develop mild symptoms by a pollen exposure for 3 hours.
3) Patients with nasal disease that affects the evaluation of the study
4) Severe respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease
5) Aldosteronism, myopathy, hypokalemia
6) Pregnant women and those at risk of pregnancy
7) Women who are planning pregnancy
8) Lactating woman
9) Patients treated with anti-allergic drugs within 2 week of screening
10) The patients who the doctor judged inappropriate for the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Okamoto
Organization Chiba University Graduate School
Division name Department of Otorhinolaryngology
Zip code 260-0856
Address 1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL 043-222-7171
Email yokamoto@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Syuji
Middle name
Last name Yonekura
Organization Chiba University Graduate School
Division name Department of Otorhinolaryngology
Zip code 260-0856
Address 1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL 043-222-7171
Homepage URL
Email syonekura@faculty.chiba-u.jp

Sponsor
Institute Department of Otorhinolaryngology in Chiba University hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Cevelopment
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Graduate School
Address 1-8-1 Inohana,Chuo-ku Chiba 260-8677
Tel 043-222-7171
Email jibika@office.chiba-u.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 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 05 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 47
Results
 47 cases participaterd in the trial and 46 cases were analized. 
 In comparison with a placebo group, total nasal symptom score at 6 hour and 9 hour from the leaving chamber was significantly lower in shoseiryuto group. However, the statistical significant difference between plasebo and shoseiryuto was not clear from 120 min to 180min in the environmental challenge chamber. 
Results date posted
2019 Year 03 Month 29 Day
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
2018 Year 07 Month 03 Day
Date of IRB
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 05 Day
Date analysis concluded
2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 05 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037952

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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