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

Not Applicable

Completed

• Conditions: Functional Constipation
• Interventions: Dietary Supplement: Ficus carica (Fig paste); Dietary Supplement: Placebo (Placebo paste)

• Registration Number: NCT01185431
• Lead Sponsor: Chonbuk National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Primary Completion: 2011-02
• Study Completion: 2011-08
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ficus carica (Fig paste)	Ficus carica (Fig paste)	-
Control (Placebo paste)	Placebo (Placebo paste)	-

Primary Outcome Measures

Name	Time	Method
Colonic transit time	116 day	Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of