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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002445
Receipt No. 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

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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
Email

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
Email jibika@office.chiba-u.jp

Sponsor
Institute Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002990

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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