UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026653 |
|---|---|
| Receipt number | R000026854 |
| Scientific Title | The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2017/03/22 19:12:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea
Acronym
The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea
Scientific Title
The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea
Scientific Title:Acronym
The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea
Region
| Japan |
Condition
Condition
sensitivity to cold
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted an experiment to clarify the improvement effect of drinking Angelica acutiloba tea on cold sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Young women who had cold sensitivity drank either Angelica acutiloba tea or hot water.After 30minutes,We conducted a cold water load test and measured changes in peripheral surface temperatures and blood flow.
Key secondary outcomes
Young women who had cold sensitivity drank either Angelica acutiloba tea or hot water for 2 weeks. We measured changes in peripheral surface temperatures and cold symptoms.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Samples is Angelica acutiloba tea 200 ml (tea leaves 3g).Contrast condition is hot water 200 ml.
The subjects were drinking tea before cold water load test 30 minutes ago.
Interventions/Control_2
Samples is Angelica acutiloba tea 200 ml (tea leaves 3g).Contrast condition is hot water 200 ml.
The subjects drank tea two weeks(Before bedtime and wake-up).
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
healthy young women
Key exclusion criteria
people who don't have symptoms of cold
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriri Kitano |
Organization
Kio university
Division name
Faculty of Health Science
Zip code
Address
4-2-2, Umaminaka, Koryo-cho Kitakatsuragi-gun, Nara
TEL
0745-54-1601
n.kitano@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriri Kitano |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
Address
4-2-2, Umaminaka, Koryo-cho Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
n.kitano@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 22 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026854
