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

This study has been completed.
Information provided by:
Chonbuk National University Hospital Identifier:
First received: August 16, 2010
Last updated: February 6, 2012
Last verified: February 2012

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

Condition Intervention
Functional Constipation Dietary Supplement: Ficus carica (Fig paste) Dietary Supplement: Placebo (Placebo paste)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Colonic transit time [ Time Frame: 116 day ]
    Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).

Secondary Outcome Measures:
  • Questionnaire for evacuation [ Time Frame: 116 day ]
    Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)

  • Questionnaire for quality of life [ Time Frame: 116 day ]
    Questionnaire include quality of life (physical function, limited role, pain, general healthy)

  • Questionnaire for woman reproductive function [ Time Frame: 116 day ]
    Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome)

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01185431

Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
Principal Investigator: Soo-Wan Chae, MD Chonbuk National University Hospital
  More Information

Responsible Party: Study Director, Chae, Soo-wan, Chonbuk National University Hospital Identifier: NCT01185431     History of Changes
Other Study ID Numbers: CTCF2_2010_YM
Study First Received: August 16, 2010
Last Updated: February 6, 2012

Keywords provided by Chonbuk National University Hospital:
Ficus Carica
Functional Constipation
Dietary Supplement
Fig Paste

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on September 20, 2017