UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030329 |
|---|---|
| Receipt number | 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 08:56:42 |
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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
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
ikumin@asahikawa-med.ac.jp
Sponsor or person
Institute
asahikawa medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034639
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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