UMIN-CTR Clinical Trial

Basic information
Public title	Longitudinal Changes of Salivary Oxytocin and Salivary Cortisol after Inhalation of Clary Sage Essential Oil Vapors: Preliminary Study
Acronym	Longitudinal changes of Oxytocin after Clary Sage Oil
Scientific Title	Longitudinal Changes of Salivary Oxytocin and Salivary Cortisol after Inhalation of Clary Sage Essential Oil Vapors: Preliminary Study
Scientific Title:Acronym	Longitudinal changes of Oxytocin after Clary Sage Oil
Region	Japan

Condition
Condition	Pregnant women between 38 and 40 weeks of gestation
Classification by specialty	Obsterics and gynecology Nursing Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	1) To examine the longitudinal changes of salivary oxytocin and salivary cortisol after inhalation of clary sage essential oil vapor. 2) To verify and confirm the feasibility of the experimental approach.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Salivary oxytocin 10 minutes before intervention and 15, 30, 60 minutes after intervention
Key secondary outcomes	Salivary cortisol 10 minutes before intervention and 15, 30, 60 minutes after intervention, Polymorphisms of oxytocin receptor

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Interventions: Vapor bubbles are produced from clary sage essential oil dissolved in propylene glycol by an air pump. Subjects inhale the vapor for 20 minutes through a tube and funnel near their nostrils
Interventions/Control_2	Control: Subjects inhale the air pumped with only propylene glycol for 20 minutes through tube and funnel near their nostrils
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	25 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	1. Low risk singleton pregnant women who are 38 weeks of gestation through 40 weeks of gestation 2. Plan to give birth with spontaneous delivery 3. Before the onset of labor 4. Asian and can read and write Japanese
Key exclusion criteria	1. Experienced prolonged pregnancy 2. Previous caesarian section 3. Recurrent miscarriages (3 consecutive) 4. Medical history of treatment of infertility 5. Planned induced labor or cesarean section 6. Planned analgesia 7. Smokes tobacco 8. Alcoholic 9. Complications of pregnancy 10. Takes medication not to related to gestation 11. Hospital visits for complication not related to gestation 12. Medical history that needs treatment or follow up 13. Some allergies of food or drug 14. Plant allergy or allergic symptoms with aromatherapy 15. Breast feeding child 16. Olfactory disorder
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeko Horiuchi
Organization	St. Luke's International University
Division name	Nursing science, Women's Health & Midwifery
Zip code
Address	10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL	03-3543-6391
Email	shigeko-horiuchi@slcn.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuriko Tadokoro
Organization	St. Luke's International University, Postgraduate School
Division name	Nursing science, Women's Health & Midwifery
Zip code
Address	3-8-5, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-6226-6361
Homepage URL
Email	14dn011@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Funding Source
Organization	MEXT KAKENHI (B)(Grant Number: 26293475)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Fumiko Yamaji grant in aid for Nursing research

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	2015 Year 06 Month 08 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	2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 09 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2015 Year 08 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 06 Day
Last modified on	2016 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020654

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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