UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032707
Receipt No. R000037114
Scientific Title Influence of ongoing sleep control by moxibustion self-care on premenstrual syndrome
Date of disclosure of the study information 2018/06/01
Last modified on 2019/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name horikawa nao
Organization Morinomiya University of Medical Sciences
Division name Department of acupuncture
Zip code
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
Middle name
Last name horikawa nao
Organization Morinomiya University of Medical Sciences
Division name Department of acupuncture
Zip code
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
Address
Tel
Email

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
2019 Year 08 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.