Back to resultsEffect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Agar jelly
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, agar
Eligibility Criteria
Inclusion Criteria:
- subjects take laxatives.
Exclusion Criteria:
- subjects underwent abdominal surgery.
Sites / Locations
- Showa Inan General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Agar jelly, constipation
Arm Description
Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks.
Outcomes
Primary Outcome Measures
the condition of feces
Bristol scale is used.
Secondary Outcome Measures
the number and amount of defecation
Full Information
NCT ID
NCT02012543
First Posted
November 9, 2013
Last Updated
November 2, 2014
Sponsor
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02012543
Brief Title
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.
Detailed Description
Each subject eats one cap of agar jelly shortly before having dinner every day for 4 weeks.
At 0, 7th, 14th, 21th, and 28th day , the frequency of defecation and defecation condition is assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, agar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Agar jelly, constipation
Arm Type
Experimental
Arm Description
Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Agar jelly
Primary Outcome Measure Information:
Title
the condition of feces
Description
Bristol scale is used.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
the number and amount of defecation
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects take laxatives.
Exclusion Criteria:
subjects underwent abdominal surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, MD
Organizational Affiliation
Showa Inan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
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