search
Back to results

The Effects of a Ficus Carica in Subjects With Functional Constipation

Primary Purpose

Functional Constipation

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ficus Carica (300g/day)
Placebo (300g/day)
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Functional Constipation

Eligibility Criteria

19 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 19 and 39 years,
  • diagnosis of functional constipation by ROME III criteria,
  • Colon transit time (CTT) ≥ 36 h,
  • subjects giving written informed consent

Exclusion Criteria:

  • allergic or hypersensitive response to any of the ingredients in the test products,
  • having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,
  • diagnosis of irritable bowel syndrome by ROME III criteria, etc,.

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ficus Carica

Placebo

Arm Description

Ficus Carica 300g/day

Placebo 300g/day

Outcomes

Primary Outcome Measures

Changes in colon transit time
Colon transit time was measured in study baseline and visit 3(8 week). Colonic transit time was measured by the method of Metcalf et al,. Subjects ingested a once-daily series of three distinctive ColomarkTM capsules at the same time each day for three consecutive days. Each capsule contained twenty radioopaque makers of a ring shape. Subjects then received abdominal X-rays 24 after the ingestion of the final capsule. Abdominal X-rays through a Number of markers present was confirmed. The CTT was calculated as the sum of the markers detected on X-ray.

Secondary Outcome Measures

Changes in frequency of defecation
Frequency of defecationI was measured in study baseline and visit 3(8 week).
Changes in defecation time
Defecation time was measured in study baseline and visit 3(8 week).
Changes in stool type
Stool type was measured in study baseline and visit 3(8 week). Stool type is composed as follows: Separate hard lumps, like nuts. (score 1); Sausage-shaped but lumpy (score 2); Like a sausage or snake but with cracks on its surface (score 3); Like a sausage or snake, smooth and soft. (score 4); Soft blobs with clear-cut edges (score 5); Fluffy pieces with ragged edges, a mushy stool (score 6); Watery, no solid pieces (score 7). The average score is closer to the three-point mode means a normal stool.
Changes in abdominal discomfort
Abdominal discomfort was measured in study baseline and visit 3(8 week). Abdominal discomfort each question is composed as follows: Very poor (score 1); Poor (score 2); Average (score 3); Good (score 4); Very good (score 5). A higher score means severe abdominal pain.

Full Information

First Posted
May 13, 2014
Last Updated
May 13, 2016
Sponsor
Chonbuk National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02138851
Brief Title
The Effects of a Ficus Carica in Subjects With Functional Constipation
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fig paste on functional constipation. The investigators measured colon transit time, frequency of defecation, defecation time, stool type, and abdominal discomfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ficus Carica
Arm Type
Experimental
Arm Description
Ficus Carica 300g/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 300g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Ficus Carica (300g/day)
Intervention Description
Ficus Carica (300g/day), parallel design
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (300g/day)
Intervention Description
Placebo (300g/day), parallel design
Primary Outcome Measure Information:
Title
Changes in colon transit time
Description
Colon transit time was measured in study baseline and visit 3(8 week). Colonic transit time was measured by the method of Metcalf et al,. Subjects ingested a once-daily series of three distinctive ColomarkTM capsules at the same time each day for three consecutive days. Each capsule contained twenty radioopaque makers of a ring shape. Subjects then received abdominal X-rays 24 after the ingestion of the final capsule. Abdominal X-rays through a Number of markers present was confirmed. The CTT was calculated as the sum of the markers detected on X-ray.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in frequency of defecation
Description
Frequency of defecationI was measured in study baseline and visit 3(8 week).
Time Frame
8 week
Title
Changes in defecation time
Description
Defecation time was measured in study baseline and visit 3(8 week).
Time Frame
8 week
Title
Changes in stool type
Description
Stool type was measured in study baseline and visit 3(8 week). Stool type is composed as follows: Separate hard lumps, like nuts. (score 1); Sausage-shaped but lumpy (score 2); Like a sausage or snake but with cracks on its surface (score 3); Like a sausage or snake, smooth and soft. (score 4); Soft blobs with clear-cut edges (score 5); Fluffy pieces with ragged edges, a mushy stool (score 6); Watery, no solid pieces (score 7). The average score is closer to the three-point mode means a normal stool.
Time Frame
8 week
Title
Changes in abdominal discomfort
Description
Abdominal discomfort was measured in study baseline and visit 3(8 week). Abdominal discomfort each question is composed as follows: Very poor (score 1); Poor (score 2); Average (score 3); Good (score 4); Very good (score 5). A higher score means severe abdominal pain.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 19 and 39 years, diagnosis of functional constipation by ROME III criteria, Colon transit time (CTT) ≥ 36 h, subjects giving written informed consent Exclusion Criteria: allergic or hypersensitive response to any of the ingredients in the test products, having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder, diagnosis of irritable bowel syndrome by ROME III criteria, etc,.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; 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 in Subjects With Functional Constipation

We'll reach out to this number within 24 hrs