Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrunus Mume Extract
Prunus Mume Extract (3.94g/day)
DIETARY_SUPPLEMENTPlacebo
Placebo (3.94g/day)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Colonic Transit Time | 8 weeks | Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week). |
| Changes in number of bowel movement | 8 weeks | Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week). |
| Changes in defecation time | 8 weeks | Defecation time was measured in study visit 1(0 week) and visit 3(8 week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in stool type | 8 weeks | Stool type was measured in study visit 1(0 week) and visit 3(8 week). |
| Changes in stool color | 8 weeks | Stool color was measured in study visit 1(0 week) and visit 3(8 week). |
| Changes in stool amounts per defecation | 8 weeks | Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week). |
Countries
South Korea
Outcome results
None listed