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

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

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: Ficus carica (Fig paste); Dietary supplement: Placebo (Placebo paste)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ficus carica (Fig paste)	Dietary supplement: Ficus carica (Fig paste); Ficus carica paste 300g/day
Placebo Comparator: Control (Placebo paste)	Dietary supplement: Placebo (Placebo paste); Placebo composition 300g/day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Principal Investigator: Soo-Wan Chae, MD, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 16, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Dietary Supplement; Functional Constipation; Ficus Carica; Fig Paste
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: CTCF2_2010_YM