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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034422
Receipt No. R000039199
Scientific Title Examination of Aromatic Bath's Efficacy in Patients with Anxiety Disorder: Confirmatory, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Collaborative and Comparative Trial
Date of disclosure of the study information 2018/10/20
Last modified on 2019/10/15

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Basic information
Public title Examination of Aromatic Bath's Efficacy in Patients with Anxiety Disorder: Confirmatory, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Collaborative and Comparative Trial
Acronym Examination of Aromatic Bath's Efficacy in Patients with Anxiety Disorder
Scientific Title Examination of Aromatic Bath's Efficacy in Patients with Anxiety Disorder: Confirmatory, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Collaborative and Comparative Trial
Scientific Title:Acronym Examination of Aromatic Bath's Efficacy in Patients with Anxiety Disorder
Region
Japan

Condition
Condition Anxiety Disorder
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether taking lavender aromatic baths reduces the dosage and dosing frequency of anxiolytic drug of the benzodiazepine class
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The dosing frequency of anxiolytic drugs
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Carry lavender scent for 4 weeks
Interventions/Control_2 Carry distilled water for 4 weeks
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria Individuals affected by generalized anxiety disorder or panic disorder
Individuals who have used anxiolytic medications more than 7 times in the past month
Individuals who do not take aromatherapy baths
Key exclusion criteria Individuals deemed unfit to be a subject in this study by the attending physician due to physical or mental strain that would result from participation in this study
Individuals who are pregnant, possibly pregnant, gave birth within the last 28 days or who are breastfeeding
Individuals with an olfactory disorder and chronic nasal obstruction
Individuals with suicidal thoughts
Individuals who take anxiolytic drugs other than benzodiazepines as a medication to be taken as needed at the time of anxiety attack
Additionally, individuals deemed ineligible to be a subject in this study by the principal investigators or co-investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Asakawa
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Division of Psychosomatic Internal Medicine
Zip code 890-8520
Address 8-35-1 Sakuragaoka Kagoshima, Japan
TEL 0992755751
Email asakawa@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Asakawa
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Division of Psychosomatic Internal Medicine
Zip code 890-8520
Address 8-35-1 Sakuragaoka Kagoshima, Japan
TEL 0992755751
Homepage URL
Email asakawa@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Division of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Division of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
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 Kagoshima University Hospital
Address Sakuragaoka 8-35-1, Kagoshima
Tel 099-275-5934
Email crmc@m2.kufm.kagoshima-u.ac.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
2018 Year 10 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 26 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 17 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 09 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039199

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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