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

Tracking Information
First Received Date ^ICMJE	November 22, 2012
Last Updated Date	November 26, 2012
Start Date ^ICMJE	August 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 22, 2012)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01734226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 22, 2012)	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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
Official Title ^ICMJE	Not Provided
Brief Summary	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Constipation
Intervention ^ICMJE	Dietary Supplement: Prunus Mume Extract Prunus Mume Extract (3.94g/day) Dietary Supplement: Placebo Placebo (3.94g/day)
Study Arm (s)	Experimental: Prunus Mume Extract Intervention: Dietary Supplement: Prunus Mume Extract Placebo Comparator: Placebo Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	19 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01734226
Other Study ID Numbers ^ICMJE	JINR-CON-PME
Has Data Monitoring Committee	Yes
Responsible Party	Soo-Wan Chae, Chonbuk National University Hospital
Study Sponsor ^ICMJE	Chonbuk National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chonbuk National University Hospital
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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