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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043654
Receipt No. R000049673
Scientific Title Aroma therapy for females with headache
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/03

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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
Email 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
Email hisyo3@heisei.or.jp

Sponsor
Institute Kurashiki Heisei Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 15 Day
Date of IRB
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
2021 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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