UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033286 |
|---|---|
| Receipt number | 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 07:04:38 |
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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
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
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Chiba University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037952
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