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Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734226
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  Purpose
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.

Condition Intervention Phase
Constipation Dietary Supplement: Prunus Mume Extract Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

Primary Outcome Measures:
  • 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).

  • 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).

  • Changes in defecation time [ Time Frame: 8 weeks ]
    Defecation time was measured in study visit 1(0 week) and visit 3(8 week).


Secondary Outcome Measures:
  • Changes in stool type [ Time Frame: 8 weeks ]
    Stool type was measured in study visit 1(0 week) and visit 3(8 week).

  • Changes in stool color [ Time Frame: 8 weeks ]
    Stool color was measured in study visit 1(0 week) and visit 3(8 week).

  • 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).


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prunus Mume Extract Dietary Supplement: Prunus Mume Extract
Prunus Mume Extract (3.94g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (3.94g/day)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734226


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Eun-Kyung Choi, MD    82-63-250-2537    ekchoi@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01734226     History of Changes
Other Study ID Numbers: JINR-CON-PME
First Submitted: November 22, 2012
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms