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

Chonbuk National University

Status

Completed

Conditions

Functional Constipation

Treatments

Dietary Supplement: Placebo (Placebo paste)

Dietary Supplement: Ficus carica (Fig paste)

Study type

Interventional

Funder types

Other

Identifiers

NCT01185431

CTCF2_2010_YM

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

Female

Ages

19 to 40 years old

Volunteers

No Healthy Volunteers

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)