Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

Chonbuk National University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Constipation

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Prunus Mume Extract

Study type

Interventional

Funder types

Other

Identifiers

NCT01734226

JINR-CON-PME

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

19 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.