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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01185431
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : February 7, 2012
Information provided by:
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

Condition or disease Intervention/treatment Phase
Functional Constipation Dietary Supplement: Ficus carica (Fig paste) Dietary Supplement: Placebo (Placebo paste) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Questionnaire for evacuation [ Time Frame: 116 day ]
    Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)

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

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

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Study Director, Chae, Soo-wan, Chonbuk National University Hospital Identifier: NCT01185431     History of Changes
Other Study ID Numbers: CTCF2_2010_YM
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 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