UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043654 |
|---|---|
| Receipt number | R000049673 |
| Scientific Title | Aroma therapy for females with headache |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/09/18 20:31:33 |
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Basic information
Public title
Aroma therapy for females with headache
Acronym
Aroma therapy for females with headache
Scientific Title
Aroma therapy for females with headache
Scientific Title:Acronym
Aroma therapy for females with headache
Region
| Japan |
Condition
Condition
migraine, tension headache
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of aromatherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and severity of headache
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aromatherapy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Diagnosed as migraine, tension headache, or both
2) Taking one or more headache medicine
3) Female
4) Age 16 or more
5) One who can provide written informed consent on her own will
6) Outpatient
Key exclusion criteria
1) Intracranial diseases within 3 months
2) Severe olfactory disturbance
3) Psychiatric diseases requiring medication
4) One who are already doing aromatherapy
5) Enrolled in other clinical trial for headache within 3 months
6) Uncontrolled organic disease
7) Dementia
8) One who are judged as not suitable for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Hishikawa |
Organization
Kurashiki Heisei Hospital
Division name
Department of Neurology
Zip code
710-0826
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
TEL
086-427-1111
nozomih.24@gmail.com
Public contact
Name of contact person
| 1st name | Setsuko |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Heisei Hospital
Division name
Medical secretary
Zip code
710-0826
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
TEL
086-427-1111
Homepage URL
hisyo3@heisei.or.jp
Sponsor or person
Institute
Kurashiki Heisei Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Okayama University
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
Kurashiki Heisei Hospital, Ethics Committee
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
Tel
086-427-1111
hisyo3@heisei.or.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
| 2021 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049673
| 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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| Registered date | File name |
