UMIN-CTR Clinical Trial

Basic information
Public title	Examination of improvement of constipation by Tanden breathing
Acronym	Examination of improvement of constipation by Tanden breathing
Scientific Title	Examination of improvement of constipation by Tanden breathing
Scientific Title:Acronym	Examination of improvement of constipation by Tanden breathing
Region	Japan

Condition
Condition	constipations
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is aimed to verify whether Tanden breathing will have an effect on improving constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	The score of the Japanese version of constipation assessment scale at each timing is defined as follows. S 12 = 6 weeks after intervention group intervention (intervention group) S10 = baseline measurement (intervention group) S02 = 6 weeks after intervention group intervention (waiting group) S00 = Baseline measurement (waiting group) Primary out comes are E {(S12 - S10) - (S02 - S00)}. Note that E (x) indicates the expected value of x.
Key secondary outcomes	S 04 = 6 weeks after waiting group intervention (waiting group) S 11 = 3 weeks after intervention group intervention (intervention group) S 03 = 3 weeks after waiting group intervention(waiting group) S01 = 3 weeks after intervention group intervention (waiting group) Perform comparison within the county in the waiting group. E (S 04 - S 02) is calculated. Calculate intra-county comparison E (S 11 - S 10) and E (S 12 - S 11) in the intervention group. Calculate intra-county comparison E (S 03 - S 02) and E (S 04 - S 03) in the waiting group. Inter-group comparison E {(S 11 - S 10) - (S 01 - S 00)} is calculated. Subjective symptoms

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Stratified randomized weight list comparison test Intervention group 6 week intervention (daily Tanden breathing for about 10 minutes)
Interventions/Control_2	Wsiting group 6 weeks waiting - 6 week intervention (daily Tanden breathing for about 10 minutes)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who are conscious of constipation symptoms during the past month of acquiring consent. Japanese version Constipation Assessment scale CAS Ver.2 - MT Person who has 5 points or more in MT with a score of 5 or more. After receiving sufficient explanation for participation in this research, those who gained document consent by their own free will with sufficient understanding.
Key exclusion criteria	1.A woman who is pregnant or has a possibility of pregnancy 2.Persons who already have custom of Tanden breathing. (Excluding those who have experience, but who are not customary.) 3.Other persons who have judged that the researcher or research cooperator is inappropriate as the research subject
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Soshi Takao
Organization	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciense
Division name	Department of Epidemiology
Zip code
Address	Shigata cho 2 - 5 - 1 basic research building 7th floor,Kita-ku,Okayama city ,Okayama prefecture
TEL	086-235-7173
Email	p17z9kt4@s.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Habu
Organization	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciense
Division name	Department of Epidemiology
Zip code
Address	Shigata cho 2 - 5 - 1 basic research building 7th floor,Kita-ku,Okayama city ,Okayama prefecture
TEL	086-235-7173
Homepage URL
Email	p17z9kt4@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2019 Year 01 Month 25 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	21
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	2018 Year 11 Month 26 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 02 Month 18 Day
Last follow-up date	2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 25 Day
Last modified on	2020 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040625