Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

Constipation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01734226
• Other study ID #: JINR-CON-PME
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 22, 2012
• Last updated: November 26, 2012
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Prunus Mume Extract
Prunus Mume Extract (3.94g/day)
• Placebo
Placebo (3.94g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Colonic Transit Time	Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes
Primary	Changes in number of bowel movement	Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes
Primary	Changes in defecation time	Defecation time was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes
Secondary	Changes in stool type	Stool type was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes
Secondary	Changes in stool color	Stool color was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes
Secondary	Changes in stool amounts per defecation	Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week).	8 weeks	Yes