The Effects of a Ficus Carica in Subjects With Functional Constipation

Functional Constipation Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138851
• Other study ID #: YGF-CON-FIG2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 13, 2014
• Last updated: May 13, 2016
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 39 Years

Eligibility

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,.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Ficus Carica (300g/day)
Ficus Carica (300g/day), parallel design
• Placebo (300g/day)
Placebo (300g/day), parallel design

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?nal 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.	8 weeks	Yes
Secondary	Changes in frequency of defecation	Frequency of defecationI was measured in study baseline and visit 3(8 week).	8 week	Yes
Secondary	Changes in defecation time	Defecation time was measured in study baseline and visit 3(8 week).	8 week	Yes
Secondary	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.	8 week	Yes
Secondary	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.	8 week	Yes