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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004874
Receipt No. R000005801
Scientific Title Elucidation of the pathology of peripheral chilliness in women and the efficacy of Tokishigyakukagoshuyushokyoto
Date of disclosure of the study information 2011/01/15
Last modified on 2016/02/15

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Basic information
Public title Elucidation of the pathology of peripheral chilliness in women and the efficacy of Tokishigyakukagoshuyushokyoto
Acronym Efficiency of Tokishigyakukagosyuyushokyoto for peripheral chilliness in women
Scientific Title Elucidation of the pathology of peripheral chilliness in women and the efficacy of Tokishigyakukagoshuyushokyoto
Scientific Title:Acronym Efficiency of Tokishigyakukagosyuyushokyoto for peripheral chilliness in women
Region
Japan

Condition
Condition peripheral chilliness
Classification by specialty
Medicine in general Cardiology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the effiency of Tokishigyakukagosyuyushokyoto for peripheral chilliness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Recovering ratio of blood flow and skin temperature in cold bathing test and objective improvement of feeling chillness after the start of protocol treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Administration of 7.5g extractive granule of Tokishigyakukagosyuyushokyoto and life style counseling for two month
Interventions/Control_2 Life style counseling for two month
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
80 years-old >
Gender Female
Key inclusion criteria Patients with objective feeling chillness for at least three years
Key exclusion criteria 1)pregnant or nursing
2)diabetes mellitus complicated by peripheral neuropathy
3)arteriosclerosis obliterans
4)Buerger's disease
5)connective tissue disease
6)hypothyroidism
7)hyperthyroidism
8)Patients medicated with following drugs every day:other Chinese herbal medicine, alpha blocker, beta blocker, alpha and blocker, calcium antagonist and prostaglandinE1
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Nishida
Organization Japanese Red Cross Wakayama Medical Center
Division name Department of Psychosomatic Medicine
Zip code
Address Komatsubaradori4-20, Wakayama city, Wakayama, Japan
TEL 073-422-4171
Email nishida777@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Nishida
Organization Japanese Red Cross Wakayama Medical Center
Division name Department of Psychosomatic Medicine
Zip code
Address Komatsubaradori4-20, Wakayama city, Wakayama, Japan
TEL 073-422-4171
Homepage URL
Email nishida777@gmail.com

Sponsor
Institute Public Health, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka Center for Cancer and Cardiovascular Diseases Prevention
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
2011 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-015-0617-4
Number of participants that the trial has enrolled
Results
At the baseline, there were no differences in clinical characteristics between the two groups. In the intervention group, peripheral coldness improved after the intervention term; however, it persisted in the control group. Mean values of percentage recovery of the peripheral blood flow after cold bathing tests were 17.2% and -28.2% for the intervention and control groups, respectively (p = 0.007), and the proportions for percentage recovery of >50% were 32% and 0%, respectively (p = 0.0007). Mean values of percent recovery of skin temperature did not differ between the two groups
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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2015 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 14 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005801

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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