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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001254
Receipt No. R000001528
Scientific Title To compare therapeutic effect of Glycyrrhizic Acid and H1-receptor antagonist for acute urticaria : a multicenter, prospective, single-blind, randomized controlled trial
Date of disclosure of the study information 2008/07/17
Last modified on 2012/07/19

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Basic information
Public title To compare therapeutic effect of Glycyrrhizic Acid and H1-receptor antagonist for acute urticaria
: a multicenter, prospective, single-blind, randomized controlled trial
Acronym To compare therapeutic effect of Glycyrrhizic Acid and H1-receptor antagonist for acute urticaria
: a multicenter, prospective, single-blind, randomized controlled trial
Scientific Title To compare therapeutic effect of Glycyrrhizic Acid and H1-receptor antagonist for acute urticaria
: a multicenter, prospective, single-blind, randomized controlled trial
Scientific Title:Acronym To compare therapeutic effect of Glycyrrhizic Acid and H1-receptor antagonist for acute urticaria
: a multicenter, prospective, single-blind, randomized controlled trial
Region
Japan

Condition
Condition acute urticaria
Classification by specialty
Medicine in general Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For the treatment of acute urticaria, use of H1-receptor antagonist is popular in Japan, although glycyrrhizic acid has been sometimes used in Japan. We aimed to assess the efficacy and safety of intravenous H1-receptor antagonist with Glycyrrhizic Acid injestion for the treatment of acute urticaria.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A visual analog scale (VAS) for pruritus as a patient's subjective measurement
Key secondary outcomes Evaluation of the itch based on a new rating scale (a 'itch score'), a final global improvement rating

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous H1-receptor antagonist (Chlorpheniramine Maleate)
Interventions/Control_2 Glycyrrhizic Acid injestion
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who are newly diagnosed as an acute moderate or severe urticaria (defined by Japanese guideline); who has had no acute urticaria in 1 month before entry; and no condition requiring emergency management.
Key exclusion criteria Patients who are unreliable in following physicians' directives; did not use of any other H1-receptor antagonists, steroids, or antiallergy agent within 48 hours before entry; have no history of contraindication of H1-receptor antagonist, Glycyrrhizic Acid injestion, or similar articles; are pregnant or in lactation period; have to drive back home by oneself; and are in other conditions at the discretion of the individual physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Watanabe
Organization Yuzawa Community Medical Center
Division name Community and family medicine
Zip code
Address 2877-1, Yuzawa, Yuzawa-machi, Minami-uonuma, Niigata, 949-6101
TEL 025-780-6543
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Watanabe
Organization Yuzawa Community Medical Center
Division name Community and family medicine
Zip code
Address 2877-1, Yuzawa, Yuzawa-machi, Minami-uonuma, Niigata, 949-6101
TEL 025-780-6543
Homepage URL
Email

Sponsor
Institute Yuzawa Community Medical Center
Institute
Department

Funding Source
Organization The Japanese Academy of Family Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Tsukuba Medical Center Hospital
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 湯沢町保健医療センター(新潟県)、筑波メディカルセンター病院(茨城県)、水戸協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 17 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 Completed
Date of protocol fixation
2007 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2008 Year 10 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
2008 Year 07 Month 17 Day
Last modified on
2012 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001528

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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