UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038860 |
|---|---|
| Receipt number | R000044233 |
| Scientific Title | Research on mechanism and prevention for the side effect of herb licorice |
| Date of disclosure of the study information | 2019/12/28 |
| Last modified on | 2019/12/10 04:01:10 |
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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
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
tnamiki@faculty.chiba-u.jp
Sponsor or person
Institute
Deptartment of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044233
