Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

Chonbuk National University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Constipation

Interventions

Prunus Mume ExtractDIETARY_SUPPLEMENT

Prunus Mume Extract (3.94g/day)

PlaceboDIETARY_SUPPLEMENT

Placebo (3.94g/day)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Changes in Colonic Transit Time

Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 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).

Time frame: 8 weeks

Changes in defecation time

Defecation time was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 8 weeks

Secondary Outcomes

Changes in stool type

Stool type was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 8 weeks

Changes in stool color

Stool color was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 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).

Time frame: 8 weeks

Data from ClinicalTrials.gov

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