Status:
COMPLETED
The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Functional Constipation
Eligibility:
FEMALE
19-40 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01185431
Start Date
July 1 2010
End Date
August 1 2011
Last Update
February 7 2012
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 561-712