UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endocrinological and cytoimmunological study of laughter for therapy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kenji Takagaki
Organization	Shimane Prefectural Central Hospital
Division name	Medical Bureau
Address	4-1-1 Himebara, Izumo, Japan
TEL	0853-22-5111
Email	dermataka@takagakidc.com

Public contact
Name of contact person	Kengo Nagasaki
Organization	Shimane Prefectural Central Hospital
Division name	Medical Bureau
Address	4-1-1 Himebara, Izumo, Japan
TEL	0853-22-5111
Homepage URL
Email	nagasaki-kengo@pref.shimane.lg.jp

Sponsor
Institute	Shimane Prefectural Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006188