UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057626 |
|---|---|
| Receipt number | R000065053 |
| Scientific Title | Effects of leg warmers with thermal fibre pile knitting on Hie (cold sensation) in mature women in a randomized controlled trial |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2026/04/18 15:34:42 |
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Basic information
Public title
Effects of acupuncture points thermal stimulation leg warmers on Hie (cold sensation) in mature women
Acronym
Effects of acupuncture points thermal stimulation leg warmers on Hie (cold sensation)
Scientific Title
Effects of leg warmers with thermal fibre pile knitting on Hie (cold sensation) in mature women in a randomized controlled trial
Scientific Title:Acronym
Effects of leg warmers with thermal stimulation on Hie (cold sensation) in mature women in a randomized controlled trial
Region
| Japan |
Condition
Condition
cold hypersensitivity in the hands and feet
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mature women (aged 18-39 years) with cold hypersensitivity in the hands and feet (CHHF) will be randomly allocated to the acupuncture thermal heat stimulation leg warmers group and the normal leg warmers group to compare the effects of 3 weeks of wear on the degree of CHHF and symptoms comorbid with CHHF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of coldness in hands and feet and six symptoms associated with coldness according to the Visual Analogue Scale (VAS) after 3 weeks of wearing the allocated leg warmers recorded one week before and after the three-week wearing of the allocated leg warmers
Key secondary outcomes
Frequency and degree of awareness of 15 symptoms comorbid with coldness according to four Likert scales recorded before and after wearing the allocated leg warmers for three weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Leg warmers with thermal fibre pile knitted at the location of the acupuncture points
Interventions/Control_2
Ordinary leg warmers with the same binding as the intervention group
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Mature women (18-39 years old) who are aware of cold hypersensitivity in the hands and feet
Key exclusion criteria
Pregnant, within 1 year postpartum, breastfeeding, taking medicines, taking Kampo medicine, receiving acupuncture within 3 months, diabetes, arteriosclerosis obliterans, Buerger's disease, collagen disease, hypothyroidism, hyperthyroidism
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Postgraduate
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-8409
sakaguti@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Postgraduate
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-8409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Okamoto Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
Tel
072-453-8409
sakaguti@kansai.ac.jp
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
| 2025 | Year | 04 | Month | 16 | 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
100
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
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065053
