UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038494 |
|---|---|
| Receipt number | R000043226 |
| Scientific Title | Effectiveness of self care with indirect moxibustion on hiesho in mature stage females Randomized controlled trial with leg warmers |
| Date of disclosure of the study information | 2019/11/05 |
| Last modified on | 2026/01/27 00:11:44 |
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Basic information
Public title
Effectiveness of self-care with indirect moxibustion for hiesho(cold disorder) in mature stage females
Acronym
Effectiveness of indirect moxibustion for hiesho in mature stage females
Scientific Title
Effectiveness of self care with
indirect moxibustion on hiesho
in mature stage
females Randomized controlled
trial with leg warmers
Scientific Title:Acronym
Effectiveness of self care with
indirect moxibustion on hiesho
in mature stage
females Randomized controlled
trial with leg warmers
Region
| Japan |
Condition
Condition
Hiesho(cold disorder)
Classification by specialty
| Medicine in general | Cardiology | Psychosomatic Internal Medicine |
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of self care with indirect moxibustion on hiesho in mature stage females with leg warmers as a cotrol by a multicenter,randomizeg controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hiesho intensity using the horizontal 100 mm Visual Analogue Scale (VAS) [Average of 1 week before and after the 4-week intervention period]
Key secondary outcomes
1 Distress of accompanying complaints (frequency of 15 symptoms multiply severity) 2Difference in skin surface temperature between forehead and LI4 LR3 and KL1.
3 Eight heading score and three component summaries of the standard edition SF36v2
Each endpoint is measured within one week before and after the intervention period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
As a self-care, before going to bed, perform indirect moxibustion KI1, SP6 and ST36. The duration is 4 weeks.
Interventions/Control_2
Wear a leg warmer (38cm length) while sleeping. The duration is 4 weeks.
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
Females with hiesho and more than four point of total score in the" hiesho sensation scale" proposed by Kusumi et al
Key exclusion criteria
1) Those who are pregnant or breastfeeding
2) Diabetes complicated with peripheral neuropathy
3) Obstructive arteriosclerosis
4) Buerger's disease
5) Collagen disease
6) Hypothyroidism
7) Hyperthyroidism
8) Persons taking the following drugs daily: Chinese medicine, alpha blocker, beta blocker, calcium antagonist, prograss coal dust E1 derivative formulation
9) Within one year after delivery
10) Within 3 months of using acupuncture
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Tsujiuchi |
Organization
Womens Oriental Medical Forum
Division name
Serie Acupuncture and Moxibustion Clinic
Zip code
231-0063
Address
1-5-704 hanasaki,naka,yokohama kanagawa Japan
TEL
045-262-5550
womf@nifty.com
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Ssakaguchi |
Organization
Kansai University of Health Sciences
Division name
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
0724538409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Womens Oriental Medical Forum
Institute
Department
Personal name
Funding Source
Organization
Training and License Screening Foundation Amma Massage Acupuncture and Moxibuchon
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
serie acupucter momibustion clinic
acupuncture and moxibustion clinic maaru
esuperansu acupuncture and moxibustion clinic
acupuncture and moxibustion clinic chiba
kansai university of health sciences
Name of secondary funder(s)
kansai university of health sciences
IRB Contact (For public release)
Organization
Serie Acupuncture and Moxibustion Clinic
Address
1-5-704 hanasaki,naka,yokohama kanagawa Japan
Tel
045-262-5550
womf@nifty.com
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
せりえ鍼灸室、鍼灸院CHIBA、エスペラァンスはりきゅう山本院、はり灸サロンまぁる/ SERIE WOMEN,S HEALTH CARE, Shin-kyu CHIBA, Pelverance Hari-kyu YAMAMOTO, Hari-kyu Salon Mal, Kansai University of Health Sciences
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kampomed/72/4/72_341/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kampomed/72/4/72_341/_pdf/-char/ja
Number of participants that the trial has enrolled
47
Results
In the leg group, one person dropped out each due to pregnancy and skin itching. The changes in VAS and pain scores were greater in the moxibustion group, showing a small effect size for VAS and a medium effect size for pain scores. The temperature difference between the forehead and Hegu was reduced in the moxibustion group, showing a medium effect size.
Results date posted
| 2026 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
Forty-nine individuals (aged 18 to 39) assessed using the cold sensitivity evaluation scale were sorted by age within four facilities and randomly assigned.
Participant flow
The moxibustion group of 25 participants applied warm moxibustion to each of the two sites before bedtime, while the leg group of 24 participants wore them at night, continuing for one month.
Adverse events
No adverse events occurred in the moxibustion group. A total of 8,400 pedestal indirect moxibustion treatments were performed without any burns. In the leg group, one person discontinued due to experiencing skin itching.
Outcome measures
The main evaluation item was the severity of cold sensitivity measured by VAS, while secondary items included the degree of discomfort from concomitant symptoms and the skin temperature difference between the forehead and the extremities.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043226
