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The Effects of a Ficus Carica in Subjects 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.
 
ClinicalTrials.gov Identifier: NCT02138851
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment Phase
Functional Constipation Dietary Supplement: Ficus Carica (300g/day) Dietary Supplement: Placebo (300g/day) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
Study Start Date : June 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Ficus Carica
Ficus Carica 300g/day
Dietary Supplement: Ficus Carica (300g/day)
Ficus Carica (300g/day), parallel design

Placebo Comparator: Placebo
Placebo 300g/day
Dietary Supplement: Placebo (300g/day)
Placebo (300g/day), parallel design




Primary Outcome Measures :
  1. Changes in colon transit time [ Time Frame: 8 weeks ]
    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 :
  1. Changes in frequency of defecation [ Time Frame: 8 week ]
    Frequency of defecationI was measured in study baseline and visit 3(8 week).

  2. Changes in defecation time [ Time Frame: 8 week ]
    Defecation time was measured in study baseline and visit 3(8 week).

  3. Changes in stool type [ Time Frame: 8 week ]
    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.

  4. Changes in abdominal discomfort [ Time Frame: 8 week ]
    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.



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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,.

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 ClinicalTrials.gov identifier (NCT number): NCT02138851


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
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Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT02138851    
Other Study ID Numbers: YGF-CON-FIG2
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive