Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 28, 2012
November 1, 2012
Same day
November 22, 2012
November 26, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in Colonic Transit Time
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in number of bowel movement
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in defecation time
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Secondary Outcomes (3)
Changes in stool type
8 weeks
Changes in stool color
8 weeks
Changes in stool amounts per defecation
8 weeks
Study Arms (2)
Prunus Mume Extract
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
November 22, 2012
First Posted
November 27, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
November 28, 2012
Record last verified: 2012-11