The Effects of a Ficus Carica in Subjects With Functional Constipation

Chonbuk National University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Functional Constipation

Interventions

Ficus Carica (300g/day)DIETARY_SUPPLEMENT

Ficus Carica (300g/day), parallel design

Placebo (300g/day)DIETARY_SUPPLEMENT

Placebo (300g/day), parallel design

Eligibility

Sex: ALLMin age: 19 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,.

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

Changes in frequency of defecation

Frequency of defecationI was measured in study baseline and visit 3(8 week).

Time frame: 8 week

Changes in defecation time

Defecation time was measured in study baseline and visit 3(8 week).

Time frame: 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.

Time frame: 8 week

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.

Time frame: 8 week

Data from ClinicalTrials.gov

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