UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025595 |
|---|---|
| Receipt number | R000029454 |
| Scientific Title | Analizing the relationship between crude drug and the sense of taste |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/12/10 08:59:37 |
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Basic information
Public title
Analizing the relationship between crude drug and the sense of taste
Acronym
Analizing the sense of taste of crude drug with other water
Scientific Title
Analizing the relationship between crude drug and the sense of taste
Scientific Title:Acronym
Analizing the sense of taste of crude drug with other water
Region
| Japan |
Condition
Condition
Pharmacy
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It's considered whether corn soup is effective to deny an unpleasant sharp taste of Zingiber siccatum. And analyzing the surface temperature of the hand and foot under the two condition(with water or with corn soup).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
non-blind study crossover comparative test is done.
The room temperature is set as 23 degree. It's kept as the temperature of the corn soup area and the lukewarm water area will be 40-50 degree beforehand. The Zingiber siccatum used here is made an over-the-counter one. Corn soup also uses something marketed. The whole subjectivity is shared with 2 groups, A and B at random by enveloped method, we record the temperature of the surface of the body side of the hand and the foot is gauged with a thermography. The difference in the A group and the B group is estimated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
A group: Tasting as well as corn soup
B group: It'll be tasted by lukewarm water.
An A group and a B group are classified by enveloped method.
Interventions/Control_2
Two weeks later, Chenging A and B.
we study the differnce of the taste and the body templature.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The adult person who is a healthy person and is prepared for implementation time of this research
Key exclusion criteria
(1) The person who complains of physical condition badness on the experimental day
(2) The person who becomes pregnant
(3) Person with allergy to ginger
(4) Person with allergy to milk
(5) Person with allergy to wheat
(6) Person with allergy to soybeans
(7) Person with allergy to pork and chicken
(8) Additionally the person who judged that a study person in charge and a common experimenter were improper
Target sample size
50
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
0166682562
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
0166682562
Homepage URL
ikumin@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
Funding Source
Organization
Own supply
Organization
Division
Category of Funding Organization
Other
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
旭川医科大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | 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 | 01 | 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=R000029454
| 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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