UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035662 |
|---|---|
| Receipt number | R000040625 |
| Scientific Title | Examination of improvement of constipation by Tanden breathing |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2020/09/27 13:30:10 |
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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
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
p17z9kt4@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040625
