UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002445 |
|---|---|
| Receipt number | R000002990 |
| Scientific Title | Double Blind, Placebo Controlled Trial of Ten-cha for Perennial Allergic Rhinitis |
| Date of disclosure of the study information | 2009/09/04 |
| Last modified on | 2011/04/25 22:39:49 |
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Basic information
Public title
Double Blind, Placebo Controlled Trial of Ten-cha for Perennial Allergic Rhinitis
Acronym
Trial of Ten-cha
Scientific Title
Double Blind, Placebo Controlled Trial of Ten-cha for Perennial Allergic Rhinitis
Scientific Title:Acronym
Trial of Ten-cha
Region
| Japan |
Condition
Condition
Prennial allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of Ten-cha for allergic rhinitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Symptom medication score
Key secondary outcomes
Medication Score
QOL score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients of Control 1 take a Ten-cha capsule three times a day for 1 month.
Interventions/Control_2
Patients of Control 2 take a placebo capsule three times a day for 1 month.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Perennial allergic rhinitis with more than moderate symtom.
2)Positive specific IgE to mite(CAP-RAST>=class2) or positive skin test to house dust.
Key exclusion criteria
1)The history of severe asthma
2)Patients who cannot stop anti-allergic drugs
3)Patients who is being treated with immunotherapy
4)Pregnant women and those at risk of pregnancy
5)Complication of the other nasal-paranasal disease
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-226-2137
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetoshi Horiguchi |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-226-2137
Homepage URL
jibika@office.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 04 | Day |
Last modified on
| 2011 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002990
| 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 |
