UMIN-CTR Clinical Trial

Basic information
Public title	Influence of ongoing sleep control by moxibustion self-care on premenstrual syndrome
Acronym	Influence of ongoing sleep control by moxibustion self-care on premenstrual syndrome
Scientific Title	Influence of ongoing sleep control by moxibustion self-care on premenstrual syndrome
Scientific Title:Acronym	Influence of ongoing sleep control by moxibustion self-care on premenstrual syndrome
Region	Japan

Condition
Condition	insomnia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, continuous sleep regulation by self-care is associated with symptoms of menstruation accompanying menstruation symptoms such as premenstrual syndrome (PMS) and dysmenorrhea (Dysmenorrhea) which appear in conjunction with female sexual cycle We will consider whether it will be useful for improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigate the symptoms of menstruation accompanying menstruation before and after menstruation and the situation of sleep and investigate whether there is an effect to ameliorate symptoms by presence or absence of moxibustion intervention to sleep disorder.
Key secondary outcomes	Using the OSA sleep questionnaire record for about 1 week before and after menstruation day, record the average value for 1 week. Record daily sleep conditions and heart rate variability using a sleep scan (TANITA sleep sensor). Record the moisture and oil elasticity value of the epidermis by the portable moisture oil elasticity meter every morning using the basal body temperature record. We will also examine the effects of moxibustion intervention on skin and basal body temperature in addition to the above indicators.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Interventions:pedestal mox The period is about 4 weeks from 1 week after menstruation to 1 week after next menstruation. The amount of stimulus was supposed to be up to the flare reaction, and it was made up to 2 tales.
Interventions/Control_2	no treatment
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	40 years-old >=
Gender	Female
Key inclusion criteria	Mature women of Pittsburgh Sleep Quality Index (PSQI) 10 and higher and Menstrual Distress Questionnaire (MDQ) high price
Key exclusion criteria	Person who is taking medicine Person who has organic disease Those receiving insomnia and a doctor's diagnosis.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name nao Middle name Last name horikawa
Organization	Morinomiya University of Medical Sciences
Division name	Department of acupuncture
Zip code	5598611
Address	1-26-16 nankoukita,suminoe-ku,oosakasi,oosaka 559-8611,Japan
TEL	06-6616-6911
Email	horikawa@morinomiya-u.ac.jp

Public contact
Name of contact person	1st name nao Middle name Last name horikawa
Organization	Morinomiya University of Medical Sciences
Division name	Department of acupuncture
Zip code	5598611
Address	1-26-16 nankoukita,suminoe-ku,oosakasi,oosaka 559-8611,Japan
TEL	06-6616-6911
Homepage URL
Email	horikawa@morinomiya-u.ac.jp

Sponsor
Institute	Morinomiya University of Medical Sciences
Institute
Department

Funding Source
Organization	Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Morinomiya University of Medical Sciences
Address	1-26-16 nankoukita,suminoe-ku,oosakasi,oosaka 559-8611,Japan
Tel	06-6616-6911
Email	horikawa@morinomiya-u.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	2018 Year 06 Month 01 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	2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 24 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037114