UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria-randomized study-
Title of the study (Brief title)	The effect of "JUMIHAIDOKUTO" on chronic urticaria
Region	Japan

Condition
Condition	chronic urticaria
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of concomitant treatment with "JUMIHAIDOKUTO" on chronic urticaria by randomized controlled trial
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) severity 2) QoL (Skindex-16) 3) Itch VAS 4) medical interview 5) recurrence
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	JUMIHAIDOKUTO+antihistamines (internventions)
Interventions/Control_2	antihistamines (control)
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with chronic urticaria suffered for over 4 weeks. 2) The symptom is difficult to treat with standard therapy with antihistamines. 3) patients whose QoL and daily activity was impaired by its symptom.
Key exclusion criteria	1) decline in physical strength 2) treated with over-dose of antihistamines 3) treated with other herbal medicine 4) treated with systemic steroid 5) with the exception of chorinergic urticaria, cold urticaria, mechanical urticaria and solar urticaria. 6) aldosteronism 7) sever heart failure 8) pregnant female
Target sample size	50

Research contact person
Name of lead principal investigator	hiROYUKI MUROTA
Organization	Osaka university
Division name	Dept. of dermatology
Address	2-2, Yamadaoka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
Organization	Osaka univeristy
Division name	dermatology
Address	2-2, yamadaoka, suita
TEL
Homepage URL
Email

Sponsor
Institute	Osaka university, dept. of dermatology
Institute
Department

Funding Source
Organization	Osaka university, dermatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 16 Day
Anticipated trial start date	2012 Year 01 Month 16 Day
Last follow-up date	2014 Year 08 Month 31 Day
Date of closure to data entry	2014 Year 08 Month 31 Day
Date trial data considered complete	2014 Year 08 Month 31 Day
Date analysis concluded	2017 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs11655-017-2950-6
Results
Other related information

Management information
Registered date	2012 Year 02 Month 08 Day
Last modified on	2018 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008549