UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032707 |
|---|---|
| Receipt number | 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 | 2021/11/25 10:17:10 |
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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
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
horikawa@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037114
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| Registered date | File name |
| Research case data | |
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