Clinical trial NCT01185431: The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: Ficus Carica
Functional Constipation
Dietary Supplement
Fig Paste
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 life and impact on female reproductive function

To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Colonic transit time
timeFrame: 116 day
Secondary outcomes:
measure: Questionnaire for evacuation
timeFrame: 116 day
measure: Questionnaire for quality of life
timeFrame: 116 day
measure: Questionnaire for woman reproductive function
timeFrame: 116 day
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Soo-Wan Chae, MD
role: PRINCIPAL_INVESTIGATOR
References: