Functional ConstipationNCT01185431
The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation
A study testing Ficus carica (Fig paste) in people with Functional Constipation, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation: To evaluate the improvement of the bowel To assess the quality of life and impact on female reproductive function To evaluate the influence on glucose, cholesterol, HDL-cholesterol… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Ficus carica (Fig paste)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Aug 2011
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who are female volunteers (unmarried), 19~40 years
- Subject who have functional constipation by ROME IIII criteria
- Subject who have over 36 hour colonic transit time
- Subject must provide written informed consent to participate in the study
Who cannot join
- Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, Cardiovascular disease
- Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- Subject with uterine fibroids at ultrasonography
- Subject is pregnant, planning to become pregnant, or breast-feeding
- Subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen
- Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN)
Show all 13Show fewer
- Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure ≤ 95 mmHg or diastolic blood pressure ≤ 60 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
- Subjects with significant hypersensitivity about Ficus carica
- Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
- Subjects who participated in other clinical investigation within 2 months prior to first administration
- Subject who drink constantly (21 units/week over)
- Subject who have Irritable bowel syndrome by ROME IIII criteria
- Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study (i.e., laboratory test and others)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Female Volunteers With Functional Constipation, to Evaluate the Improvement in Bowl Movement of Ficus Carica
This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation:
To evaluate the improvement of the bowel
To assess the quality of life and impact on female reproductive function
To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol
- Conditions
- Functional Constipation
- Being tested
- Ficus carica (Fig paste), Placebo (Placebo paste)
- Keywords
- Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ficus carica (Fig paste)Dietary supplement
Ficus carica paste 300g/day
Placebo (Placebo paste)Dietary supplement
Placebo composition 300g/day
| Study group | Role | What they receive |
|---|---|---|
| Ficus carica (Fig paste) | Experimental | Not described Receives: Dietary Supplement: Ficus carica (Fig paste) |
| Control (Placebo paste) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (Placebo paste) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic transit time
Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).
Measured: 116 day
Secondary outcomes (3)
Questionnaire for evacuation
Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)
Measured: 116 day
Questionnaire for quality of life
Questionnaire include quality of life (physical function, limited role, pain, general healthy)
Measured: 116 day
Questionnaire for woman reproductive function
Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome)
Measured: 116 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Soo-Wan Chae, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185431
- Sponsor's protocol ID
- CTCF2_2010_YM
- Status last verified
- Feb 2012
- First submitted
- 16 Aug 2010
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Female Volunteers With Functional Constipation, to Evaluate the Improvement in Bowl Movement of Ficus Carica
- ClinicalTrials.gov ID
- NCT01185431
- Acronym / sponsor ID
- CTCF2_2010_YM
- Conditions
- Functional Constipation
- Keywords
- Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Aug 2010 (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.
This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation:
To evaluate the improvement of the bowel
To assess the quality of life and impact on female reproductive function
To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ficus carica (Fig paste) | Experimental | Dietary Supplement: Ficus carica (Fig paste) |
| Control (Placebo paste) | Placebo comparator | Dietary Supplement: Placebo (Placebo paste) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who are female volunteers (unmarried), 19~40 years
- Subject who have functional constipation by ROME IIII criteria
- Subject who have over 36 hour colonic transit time
- Subject must provide written informed consent to participate in the study
Key exclusion criteria (13 listed)
- Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, Cardiovascular disease
- Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- Subject with uterine fibroids at ultrasonography
- Subject is pregnant, planning to become pregnant, or breast-feeding
- Subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen
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 |
|---|---|---|
| Ficus carica (Fig paste)Ficus carica paste 300g/day | Dietary supplement | Ficus carica (Fig paste) |
| Placebo (Placebo paste)Placebo composition 300g/day | Dietary supplement | Control (Placebo paste) |
Primary outcome
Colonic transit time
Time frame: 116 day
Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).
3 secondary outcomes
Questionnaire for evacuation
Time frame: 116 day
Questionnaire for quality of life
Time frame: 116 day
Questionnaire for woman reproductive function
Time frame: 116 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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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.
Soo-Wan Chae, MD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ficus carica (Fig paste) in people with Functional 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 13 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: finished, as of the sponsor's last update on 7 Feb 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic transit time (time frame: 116 day). 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 7 Feb 2012.