ConstipationPhase 2/3NCT01734226
Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
A Phase 2/3 study testing Prunus Mume Extract in people with Constipation, run by Chonbuk National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Prunus Mume Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
Eun-Kyung Choi, MD, 82-63-250-2537, ekchoi@jbctc.org
About this study
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.
- Conditions
- Constipation
- Being tested
- Prunus Mume Extract, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prunus Mume ExtractDietary supplement
Prunus Mume Extract (3.94g/day)
PlaceboDietary supplement
Placebo (3.94g/day)
| Study group | Role | What they receive |
|---|---|---|
| Prunus Mume Extract | Experimental | Not described Receives: Dietary Supplement: Prunus Mume Extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Colonic Transit Time
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Changes in number of bowel movement
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Changes in defecation time
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Secondary outcomes (3)
Changes in stool type
Stool type was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Changes in stool color
Stool color was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Changes in stool amounts per defecation
Stool amounts per defecation was measured in study visit 1(0 week) and visit 3(8 week).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734226
- Sponsor's protocol ID
- JINR-CON-PME
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
- ClinicalTrials.gov ID
- NCT01734226
- Acronym / sponsor ID
- JINR-CON-PME
- Conditions
- Constipation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prunus Mume Extract | Experimental | Dietary Supplement: Prunus Mume Extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prunus Mume ExtractPrunus Mume Extract (3.94g/day) | Dietary supplement | Prunus Mume Extract |
| PlaceboPlacebo (3.94g/day) | Dietary supplement | Placebo |
Primary outcome
Changes in Colonic Transit Time
Time frame: 8 weeks
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
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
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
3 secondary outcomes
Changes in stool type
Time frame: 8 weeks
Changes in stool color
Time frame: 8 weeks
Changes in stool amounts per defecation
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prunus Mume Extract in people with Constipation, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Colonic Transit Time (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.