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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024894
Receipt No. R000028617
Scientific Title Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Date of disclosure of the study information 2016/11/18
Last modified on 2017/05/16

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Basic information
Public title Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Acronym Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Scientific Title Investigation of the transdermal absorption effect of clary sage essential oil on hot flashes of menopausal women
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomoko Akase
Organization Yokohama City University
Division name Department of Biological Science and Nursing, Graduate School of Medicine
Zip code
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
1st name
Middle name
Last name Tomoko Akase
Organization Yokohama City University
Division name Department of Biological Science and Nursing, Graduate School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 07 Month 01 Day
Date of IRB
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

Other
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

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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