The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation

Study Overview
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Brief Summary
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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

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Female Volunteers With Functional Constipation, to Evaluate the Improvement in Bowl Movement of Ficus Carica

Conditions
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Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Ficus carica (Fig paste)
* Dietary Supplement: Placebo (Placebo paste)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ficus carica (Fig paste)<br> | Dietary Supplement: Ficus carica (Fig paste)<br>* Ficus carica paste 300g/day<br>|
| Placebo Comparator: Control (Placebo paste)<br> | Dietary Supplement: Placebo (Placebo paste)<br>* Placebo composition 300g/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic transit time | Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day). | 116 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire for evacuation | Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color) | 116 day | 
| Questionnaire for quality of life | Questionnaire include quality of life (physical function, limited role, pain, general healthy) | 116 day | 
| Questionnaire for woman reproductive function | Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome) | 116 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste