Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014