Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

Study Overview
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Brief Summary
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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.

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Prunus Mume Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prunus Mume Extract<br> | Dietary Supplement: Prunus Mume Extract<br>* Prunus Mume Extract (3.94g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (3.94g/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in stool type | Stool type was measured in study visit 1(0 week) and visit 3(8 week). | 8 weeks | 
| Changes in stool color | Stool color was measured in study visit 1(0 week) and visit 3(8 week). | 8 weeks | 
| Changes in stool amounts per defecation | Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week). | 8 weeks |