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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038494
Receipt No. 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 2019/11/05

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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 indirect
moxibustion on hiesho in mature
stage females A multicenter,
Randomized Prospective
controlled trial
Region
Japan

Condition
Condition Hiesho(cold disorder)
Classification by specialty
Medicine in general Cardiology Psychosomatic Internal Medicine
Obsterics 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
Email 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
Email sakaguti@kansai.ac.jp

Sponsor
Institute Womens Oriental Medical Forum
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 07 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 02 Month 20 Day
Date analysis concluded
2020 Year 03 Month 10 Day

Other
Other related information

Management information
Registered date
2019 Year 11 Month 05 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043226

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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