UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046447 |
|---|---|
| Receipt number | R000052996 |
| Scientific Title | Verification of the effect of self-care moxibustion |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/01/06 12:08:40 |
* 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
Effects of self-care moxibustion for menstrual pain
Acronym
The role of self-care moxibustion for menstrual pain
Scientific Title
Verification of the effect of self-care moxibustion
Scientific Title:Acronym
Verification of the effect of self-care moxibustion
Region
| Japan |
Condition
Condition
Menstrual pain
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of self-moxibustion for menstrual pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
VAS
Key secondary outcomes
MDQ, HADS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Self moxibustion
Have the abdomen (Sekimoto) and lower legs (Saninko) use one each at home at least three times a week.
Interventions/Control_2
No treatment
follow-up
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
1. There is no organic cause related to peripheral symptoms of menstruation
2. Do not have gynecological diseases
3. It is a regular menstrual cycle
Key exclusion criteria
1. Do not receive other treatments
2. Do not provide other self-care for menstrual pain
3. When new treatment is started during the research period
4. When the type or amount of analgesic changes
5. If you cannot use warm moxibustion more than 3 times a week
6. No big event is planned to change menstruation
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibiustion
Zip code
629-0392
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
0771721181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Sitoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibiustion
Zip code
629-0392
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
0771721181
Homepage URL
k_itoh@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji University of Integrative Medicine
Address
Hiyoshi-cho, Nantan, Kyoto
Tel
0771721181
sec_scie@meiji-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
明治国際医療大学 鍼灸センター（京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052996
