UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054180 |
|---|---|
| Receipt number | R000058661 |
| Scientific Title | Efficacy of acupuncture self-care patch for migraine |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/17 16:05:48 |
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Basic information
Public title
Efficacy of acupuncture self-care patch for migraine
Acronym
Efficacy of acupuncture self-care patch for migraine
Scientific Title
Efficacy of acupuncture self-care patch for migraine
Scientific Title:Acronym
Efficacy of acupuncture self-care patch for migraine
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the efficacy of the two patch systems as a self-administered acupuncture treatment for migraine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
headache days
Key secondary outcomes
Responder rate
Medication days
Headache Impact Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
needle patch
Interventions/Control_2
non-needle patch
Interventions/Control_3
control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Has migraine with or without aura based on the International Classification of Headache Disorders, 3rd edition.
II. 18 years of age or older.
III. Migraine attacks three or more times a month.
IV. Capable of obtaining informed consent in writing.
V. Has not changed or added prophylactic medication for migraines for more than three months.
Key exclusion criteria
The other type of headache
Has a history of severe mental illness, and/or is currently undergoing treatment for a mental disorder.
Pregnant or breastfeeding
Receiving acupuncture treatment elsewhere.
Experiences migraine attacks two or fewer times per month.
Has used calcitonin gene-related peptide antibody drugs in the past three months.
Is currently receiving treatment for malignant tumors.
Has a hemorrhagic disease.
Has a metal allergy.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sumire |
| Middle name | |
| Last name | ISHIYAMA |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center of Medical Sciences
Zip code
3000394
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
TEL
0298884000
ishiyamasu@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Sumire |
| Middle name | |
| Last name | ISHIYAMA |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center of Medical Sciences
Zip code
3000394
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
TEL
0298884000
Homepage URL
ishiyamasu@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2, Ami-machi, Ami, Ibaraki, Japan
Tel
0298884000
ishiyamasu@ipu.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
| 2024 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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