Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

November 26, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Recruiting
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo (3.94g/day)
Experimental: Prunus Mume Extract
Dietary supplement: Prunus Mume Extract
Prunus Mume Extract (3.94g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Colonic Transit Time
Time Frame: 8 weeks
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in number of bowel movement
Time Frame: 8 weeks
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in defecation time
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Stool type was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in stool color
Time Frame: 8 weeks
Stool color was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks
Changes in stool amounts per defecation
Time Frame: 8 weeks
Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 22, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JINR-CON-PME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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