UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The improvement effect of cold sensitivity by drinking of the Angelica acutiloba tea
Title of the study (Brief title)	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	Noriri Kitano
Organization	Kio university
Division name	Faculty of Health Science
Address	4-2-2, Umaminaka, Koryo-cho Kitakatsuragi-gun, Nara
TEL	0745-54-1601
Email	n.kitano@kio.ac.jp

Public contact
Name of contact person	Noriri Kitano
Organization	Kio University
Division name	Faculty of Health Science
Address	4-2-2, Umaminaka, Koryo-cho Kitakatsuragi-gun, Nara
TEL	0745-54-1601
Homepage URL
Email	n.kitano@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026854