UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024894 |
|---|---|
| Receipt number | 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 19:18:09 |
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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
| Obstetrics 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
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
akase@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028617
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