UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001254
Receipt number 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 09:49:01

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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 or person

Institute

Yuzawa Community Medical Center

Institute

Department

Personal name



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

Value
https://center6.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