UMIN-CTR Clinical Trial

Basic information
Public title	Research on the side effects of herb licorice
Acronym	Study on side effects of licorice
Scientific Title	Research on mechanism and prevention for the side effect of herb licorice
Scientific Title:Acronym	Research on mechanism and prevention for the side effect of licorice
Region	Japan

Condition
Condition	all
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of mechanism of pseudoaldosteronism caused by licorice
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of blood and urine samples
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient taking any kamopmedicnes
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Namiki
Organization	Graduate School of Medicine, Chiba University
Division name	Deptartment of Japanese-Oriental (Kampo) Medicine,
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba city
TEL	+81-432262984
Email	tnamiki@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Namiki
Organization	Graduate School of Medicine, Chiba University
Division name	Deptartment of Japanese-Oriental (Kampo) Medicine,
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba city
TEL	+81-432262984
Homepage URL
Email	tnamiki@faculty.chiba-u.jp

Sponsor
Institute	Deptartment of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Developmnt
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba city
Tel	0432227171
Email	crc-kikaku@ML.chiba-u.jp

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	2019 Year 12 Month 28 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	Enrolling by invitation
Date of protocol fixation	2011 Year 12 Month 27 Day
Date of IRB	2012 Year 01 Month 16 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Using the information of age and sex as well as serum potassium levels obtained by ordinary blood tests as reference data, We measure glycyrrhizic acid metabolites in the blood and urine of patients taking Kampo medicine.

Management information
Registered date	2019 Year 12 Month 12 Day
Last modified on	2019 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044233