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Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Chonbuk National University Hospital.
Recruitment status was  Recruiting
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

November 22, 2012
November 26, 2012
August 2012
August 2012   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01734226 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Constipation
  • Dietary Supplement: Prunus Mume Extract
    Prunus Mume Extract (3.94g/day)
  • Dietary Supplement: Placebo
    Placebo (3.94g/day)
  • Experimental: Prunus Mume Extract
    Intervention: Dietary Supplement: Prunus Mume Extract
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 40 Years
Yes
Korea, Republic of
 
NCT01734226
JINR-CON-PME
Yes
Soo-Wan Chae, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Not Provided
Chonbuk National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP