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

NCT ID: NCT01185431

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-08-31

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

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ficus carica (Fig paste)

Group Type: EXPERIMENTAL

Ficus carica (Fig paste)

Intervention Type: DIETARY_SUPPLEMENT

Ficus carica paste 300g/day

Control (Placebo paste)

Group Type: PLACEBO_COMPARATOR

Placebo (Placebo paste)

Intervention Type: DIETARY_SUPPLEMENT

Placebo composition 300g/day

Interventions

Ficus carica (Fig paste)

Ficus carica paste 300g/day

Intervention Type: DIETARY_SUPPLEMENT

Placebo (Placebo paste)

Placebo composition 300g/day

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chonbuk National University Hospital

Principal Investigators

Soo-Wan Chae, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

CTCF2_2010_YM

Identifier Type: -

Identifier Source: org_study_id