UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004874 |
|---|---|
| Receipt number | 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 01:36:46 |
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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
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
nishida777@gmail.com
Sponsor or person
Institute
Public Health, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005801
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
