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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185431
• Other study ID #: CTCF2_2010_YM
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: February 6, 2012
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Ficus carica (Fig paste)
Ficus carica paste 300g/day
• Placebo (Placebo paste)
Placebo composition 300g/day

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic transit time	Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).	116 day	Yes
Secondary	Questionnaire for evacuation	Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)	116 day	Yes
Secondary	Questionnaire for quality of life	Questionnaire include quality of life (physical function, limited role, pain, general healthy)	116 day	Yes
Secondary	Questionnaire for woman reproductive function	Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome)	116 day	Yes