search
Back to results

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

Primary Purpose

Functional Constipation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ficus carica (Fig paste)
Placebo (Placebo paste)
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

  • Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ficus carica (Fig paste)

Control (Placebo paste)

Arm Description

Outcomes

Primary Outcome Measures

Colonic transit time
Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).

Secondary Outcome Measures

Questionnaire for evacuation
Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)
Questionnaire for quality of life
Questionnaire include quality of life (physical function, limited role, pain, general healthy)
Questionnaire for woman reproductive function
Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome)

Full Information

First Posted
August 16, 2010
Last Updated
February 6, 2012
Sponsor
Chonbuk National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01185431
Brief Title
The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
Ficus Carica, Functional Constipation, Dietary Supplement, Fig Paste

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ficus carica (Fig paste)
Arm Type
Experimental
Arm Title
Control (Placebo paste)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ficus carica (Fig paste)
Intervention Description
Ficus carica paste 300g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (Placebo paste)
Intervention Description
Placebo composition 300g/day
Primary Outcome Measure Information:
Title
Colonic transit time
Description
Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).
Time Frame
116 day
Secondary Outcome Measure Information:
Title
Questionnaire for evacuation
Description
Questionnaire include evacuation pattern (defecation frequency, times, senssation, abdominal displeasure, pain, stool shape, color)
Time Frame
116 day
Title
Questionnaire for quality of life
Description
Questionnaire include quality of life (physical function, limited role, pain, general healthy)
Time Frame
116 day
Title
Questionnaire for woman reproductive function
Description
Questionnaire include woman reproductive function (menstrual cycle, premenstrual syndrome)
Time Frame
116 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Wan Chae, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs