Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01185431
First received: August 16, 2010
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)

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

  • Questionnaire for woman reproductive function [ Time Frame: 116 day ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185431

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

No publications provided

Responsible Party: Study Director, Chae, Soo-wan, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01185431     History of Changes
Other Study ID Numbers: CTCF2_2010_YM
Study First Received: August 16, 2010
Last Updated: February 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014