UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051217 |
|---|---|
| Receipt number | R000058397 |
| Scientific Title | Efficacy and safety of sleep hygiene education and yokukansan for insomnia |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/08/05 11:51:14 |
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Basic information
Public title
Efficacy and safety of sleep hygiene education and yokukansan for insomnia
Acronym
Efficacy and safety of sleep hygiene education and Kampo medicine for insomnia
Scientific Title
Efficacy and safety of sleep hygiene education and yokukansan for insomnia
Scientific Title:Acronym
Efficacy and safety of sleep hygiene education and Kampo medicine for insomnia
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of sleep hygiene education and yokukansan for patients with insomnia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Insomnia Severity Index(ISI-J)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age >= 18 y.o.
Patients who have obtained their consent
Key exclusion criteria
Pregnant or possibly pregnant
Patients with a history of mental illness such as depression or schizophrenia, or physical illness that affects insomnia
Patients who have received anti-anxiety and/or sleep medication within 4 weeks prior to enrollment in this study
Patients who have received kampo medicines preparations within 4 weeks prior to enrollment in this study
Participants who are judged to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ozone |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
67 Asahi -machi , Kurume, Fukuoka, Japan
TEL
0942-31-7564
ozone_motohiro@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Ozone |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
67 Asahi -machi , Kurume, Fukuoka, Japan
TEL
0942-31-7564
Homepage URL
i_rinri@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center in Kurume University
Address
67 Asahi -machi , Kurume, Fukuoka, Japan
Tel
0942-65-3749
i_rinri@kurume-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
| 2023 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy and safety of sleep hygiene education and yokukansan for insomnia
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058397
