UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049673