Functional Constipation
Conditions
Keywords
Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste
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
Interventions
DIETARY_SUPPLEMENTFicus carica (Fig paste)
Ficus carica paste 300g/day
DIETARY_SUPPLEMENTPlacebo (Placebo paste)
Placebo composition 300g/day
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonic transit time | 116 day | Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire for evacuation | 116 day | Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color) |
| Questionnaire for quality of life | 116 day | Questionnaire include quality of life (physical function, limited role, pain, general healthy) |
| Questionnaire for woman reproductive function | 116 day | Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome) |
Countries
South Korea
Outcome results
None listed