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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02012543
Other study ID # Agar jelly
Secondary ID Kanten1
Status Completed
Phase N/A
First received November 9, 2013
Last updated November 2, 2014
Start date November 2013
Est. completion date October 2014

Study information

Verified date November 2014
Source Showa Inan General Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- subjects take laxatives.

Exclusion Criteria:

- subjects underwent abdominal surgery.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Agar jelly


Locations

Country Name City State
Japan Showa Inan General Hospital Komagane Nagano

Sponsors (1)

Lead Sponsor Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary the condition of feces Bristol scale is used. 4 weeks No
Secondary the number and amount of defecation 4 weeks No
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