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Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

This study is currently recruiting participants.
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01734226
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in Colonic Transit Time [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Stool type was measured in study visit 1(0 week) and visit 3(8 week).

  • Changes in stool color [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 22, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013