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Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

NCT ID: NCT01734226

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Prunus Mume Extract

Group Type EXPERIMENTAL

Prunus Mume Extract

Intervention Type DIETARY_SUPPLEMENT

Prunus Mume Extract (3.94g/day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (3.94g/day)

Interventions

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Prunus Mume Extract

Prunus Mume Extract (3.94g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (3.94g/day)

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Eun-Kyung Choi, MD

Role: primary

Other Identifiers

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JINR-CON-PME

Identifier Type: -

Identifier Source: org_study_id