Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

Phase 2

• Conditions: Constipation
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Prunus Mume Extract

• Registration Number: NCT01734226
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-22
• Last Update Submitted: 2012-11-26
• Study First Posted: 2012-11-27
• Last Update Posted: 2012-11-28
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Prunus Mume Extract	Prunus Mume Extract	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of