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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030329
Receipt No. R000034639
Scientific Title Improvement effect of the easiness of drink of the kampo medicines by the combination of crude drug product
Date of disclosure of the study information 2019/01/01
Last modified on 2017/12/10

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Basic information
Public title Improvement effect of the easiness of drink of the kampo medicines by the combination of crude drug product
Acronym Improvement effect of the easiness of drink of kampo medicines by the combination of crude drug product
Scientific Title Improvement effect of the easiness of drink of the kampo medicines by the combination of crude drug product
Scientific Title:Acronym Improvement effect of the easiness of drink of kampo medicines by the combination of crude drug product
Region
Japan

Condition
Condition Effect of the kampo medicines
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure minimum nikawaame content to make it easy to hold down a sharp taste, with zingiber officinale and zanthoxylum piperitum. And we consider quantity of prescription to maximize the remedy rate of the patient and an effect of the kampo medicines.
Basic objectives2 Others
Basic objectives -Others We measure minimum nikawaame content to make it easy to hold down a sharp taste, with zingiber officinale and zanthoxylum piperitum. And we consider quantity of prescription to maximize the remedy rate of the patient and an effect of the kampo medicines.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We check the primeary outcomes among the taste, the smell, and the sense of incongruity of the throat by the combination of crude drug product.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 We make 8 kinds of hot drink water with
zingiber officinale and zanthoxylum piperitum.(Total 160ml)We add nikawaame content each cups. And we check how test subject feel the each drinks.



Interventions/Control_2 We make 8 kinds of hot drink water with
zingiber officinale and zanthoxylum piperitum.(Total 160ml)We add nikawaame content each cups. And we check how test subject feel the each drinks.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Students of Asahikawa Medical College which obtained its consent and the staff of a school a subject.
Key exclusion criteria (1)The person which is poor condition
(2)Pregnacy women
(3)The person which do not drink nikawaame content,zingiber officinale and zanthoxylum piperitum.
(4)Inadequate person
(5)Member of this research project


Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhito Kato
Organization Asahikawa medical university
Division name obstetrics and gynecology
Zip code
Address Asahikawa city midorigaoka higashi 2-1-1-1
TEL 0166-68-2562
Email ikumin@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhito Kato
Organization Asahikawa medical university
Division name obstetrics and gynecology
Zip code
Address Asahikawa city midorigaoka higashi 2-1-1-1
TEL 0166-68-2562
Homepage URL
Email ikumin@asahikawa-med.ac.jp

Sponsor
Institute asahikawa medical university


Institute
Department

Funding Source
Organization asahikawa medical university

Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 10 Day
Last modified on
2017 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=R000034639

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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