UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007823 |
|---|---|
| Receipt number | R000009221 |
| Scientific Title | The Efficacy of Laxatives and Hot Compresses for Constipation on Severity and Quality of Life in Women |
| Date of disclosure of the study information | 2012/04/23 |
| Last modified on | 2013/03/06 15:37:23 |
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Basic information
Public title
The Efficacy of Laxatives and Hot Compresses for Constipation
on Severity and Quality of Life in Women
Acronym
The Efficacy of Laxatives and Hot Compresses for Constipation
on Severity and Quality of Life in Women
Scientific Title
The Efficacy of Laxatives and Hot Compresses for Constipation
on Severity and Quality of Life in Women
Scientific Title:Acronym
The Efficacy of Laxatives and Hot Compresses for Constipation
on Severity and Quality of Life in Women
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of hot compresses with that of drug intake for constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of constipation and QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
hot compresses
Interventions/Control_2
drug intake
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
They are aware of their constipation condition for one year or more.
They have five or more scores of the Constipation Assessment Scale.
Key exclusion criteria
They could not read or speak Japanese;
They have taken the medicine which the doctor prescribed to constipation condition.
They are the secondary constipation condition there is an organic defecation obstacle or according to other diseases and the side effects of drug intake.
There is possibility of the inside of the present pregnancy or pregnancy, or it is under breast-feeding.
They have caused the skin obstacle with the sheet in the past.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kira Izumi |
Organization
SSt. Luke's College of Nursing
Division name
doctoral course
Zip code
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Luke's College of Nursing
Division name
doctoral course
Zip code
Address
TEL
03-3543-6391
Homepage URL
Sponsor or person
Institute
St. Luke's College of Nursing
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 04 | Month | 23 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 23 | Day |
Last modified on
| 2013 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
