UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034422 |
|---|---|
| Receipt number | 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 | 2023/11/24 09:56:25 |
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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
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
asakawa@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Division of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
