UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Title of the study (Brief title)	Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Region	Japan

Condition
Condition	Menopause(hot flashes)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the number of hot flashes and the degree of reduction of hot flashes compared with the control group by transdermally absorbing clathaceous essential oil by female patients complaining of hot flashes of menopausal disorder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluate the following items 21 days after the start of intervention. Symptom change of hot flashes: Evaluation of change occurring in the number of times and degree of hot flash by hot flash memory. Estrogenic activity: For each test, about 20 ml of urine is collected on the first day and the last day of the test and E2, FSH, LH are chromatographed, and the difference in hormone levels occurring between the intervention group and the control group is evaluated. Physical symptom change of menopausal disorder: Relative evaluation in somatic symptom change of 14 items described in hot flash memory
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intervention group (percutaneous absorption group) Apply 1 ml of clary sage essential oil diluted 2% in jojoba oil to the lower abdomen for 10 minutes. The essential oil is used at the front of the lower abdomen, and the application method is a procedure that does not apply pressure. 1 time/day 21 days in the same time zone.
Interventions/Control_2	Control group Apply 1 ml of clary sage essential oil of the same dilution concentration as the intervention group to a material that can not absorb percutaneously, apply it to the lower abdomen and make only fragrance of 10 minutes. Do not use your fingers when applying, use a plastic spatula. 1 time/day 21 days in the same time zone.
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	45 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	Yokohama Port Side Female General Clinic Patient, Zushi Medicine Clinic Patient Yokohama City University staff, Yokohama City University affiliated hospital staff, Yokohama City University attached citizen general medical center staff
Key exclusion criteria	(1)HRT was enforced within 30 days before the start of the study. (Women 's medicine and supplements of Chinese herbal medicine and general medicine not containing estrogen preparation are acceptable.) (2)Allergy against essential oil used (3)There is skin disease (4)HRT and Surgical menopause treatment is in effect (5)Menopausal symptom interview sheet (Document IV) There are other diseases that fall under Q4 (2) - (16) (not limited to the presence or absence of treatment) (6)Participate in other exams within 30 days before the exam (7)In addition, patients judged unsuitable as subjects by doctor's judgment
Target sample size	60

Research contact person
Name of lead principal investigator	Tomoko Akase
Organization	Yokohama City University
Division name	Department of Biological Science and Nursing, Graduate School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL	045-787-2743
Email	akase@yokohama-cu.ac.jp

Public contact
Name of contact person	Tomoko Akase
Organization	Yokohama City University
Division name	Department of Biological Science and Nursing, Graduate School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL	045-787-2743
Homepage URL
Email	akase@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 18 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028617