UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005207 |
|---|---|
| Receipt number | R000006188 |
| Scientific Title | Endocrinological and cytoimmunological study of laughter for therapy |
| Date of disclosure of the study information | 2011/03/14 |
| Last modified on | 2016/05/27 18:24:27 |
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Basic information
Public title
Endocrinological and cytoimmunological study of laughter for therapy
Acronym
Endocrinological and cytoimmunological study of laughter
Scientific Title
Endocrinological and cytoimmunological study of laughter for therapy
Scientific Title:Acronym
Endocrinological and cytoimmunological study of laughter
Region
| Japan |
Condition
Condition
Normal human
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the time course investigation of the laughter on endocrinology and cellular immunity.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Time course changes of cortisol, ACTH, NK cell activity after the laughter.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were age between 20 and 65years old, healthy cancidates who enrolled to be the
subject of this study.
Key exclusion criteria
1.candidates to be excluded who are taking psychotropic drugs
2.candidates to be excluded who are taking immunosuppressants
3.candidates to be excluded who are taking anti-allergic drugs
4.candidates to be excluded who are taking botanical supplements
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Takagaki |
Organization
Shimane Prefectural Central Hospital
Division name
Medical Bureau
Zip code
Address
4-1-1 Himebara, Izumo, Japan
TEL
0853-22-5111
dermataka@takagakidc.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Nagasaki |
Organization
Shimane Prefectural Central Hospital
Division name
Medical Bureau
Zip code
Address
4-1-1 Himebara, Izumo, Japan
TEL
0853-22-5111
Homepage URL
nagasaki-kengo@pref.shimane.lg.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
島根県立中央病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 09 | Month | 29 | Day |
Other
Other related information
The time course changes of serum cortisol, ACTH and NK cell-activity before and after laughter(2 min.).
The timings of investigations are before laughter and immediate, 15min., 30min., 60min., 90min., 120min. after laughter.
Management information
Registered date
| 2011 | Year | 03 | Month | 07 | Day |
Last modified on
| 2016 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006188
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
