Back to resultsEfficacy and Safety of Prunus Mume Extract on Improvement of Constipation
Primary Purpose
Constipation
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prunus Mume Extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- Males and females 19-40 years old
- Subject who have functional constipation by ROME IIII criteria
- Subject who have over 36 hour colonic transit time
- Able to give informed consent
Exclusion Criteria:
- Subject who have Irritable bowel syndrome by ROME IIII criteria
- Allergic or hypersensitive to any of the ingredients in the test products
- History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- History of alcohol or substance abuse
- Participation in any other clinical trials within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- Pregnant or lactating women etc.
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prunus Mume Extract
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes in Colonic Transit Time
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
Changes in number of bowel movement
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
Changes in defecation time
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
Secondary Outcome Measures
Changes in stool type
Stool type was measured in study visit 1(0 week) and visit 3(8 week).
Changes in stool color
Stool color was measured in study visit 1(0 week) and visit 3(8 week).
Changes in stool amounts per defecation
Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week).
Full Information
NCT ID
NCT01734226
First Posted
November 22, 2012
Last Updated
November 26, 2012
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01734226
Brief Title
Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of Constipation. The investigators measured Improvement of Constipation parameters , including Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool amounts per defecation, and monitored their blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prunus Mume Extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Prunus Mume Extract
Intervention Description
Prunus Mume Extract (3.94g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (3.94g/day)
Primary Outcome Measure Information:
Title
Changes in Colonic Transit Time
Description
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
Title
Changes in number of bowel movement
Description
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
Title
Changes in defecation time
Description
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in stool type
Description
Stool type was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
Title
Changes in stool color
Description
Stool color was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
Title
Changes in stool amounts per defecation
Description
Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females 19-40 years old
Subject who have functional constipation by ROME IIII criteria
Subject who have over 36 hour colonic transit time
Able to give informed consent
Exclusion Criteria:
Subject who have Irritable bowel syndrome by ROME IIII criteria
Allergic or hypersensitive to any of the ingredients in the test products
History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
History of alcohol or substance abuse
Participation in any other clinical trials within past 2 months
Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
Pregnant or lactating women etc.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Kyung Choi, MD
Phone
82-63-250-2537
Email
ekchoi@jbctc.org
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
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