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Completed

NCT Number: NCT02138851

The Effects of a Ficus Carica in Subjects With Functional Constipation

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.

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Key information

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,.

Treatment and study plan

Ficus Carica (300g/day)

Dietary Supplement

Ficus Carica (300g/day), parallel design

Placebo (300g/day)

Dietary Supplement

Placebo (300g/day), parallel design

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 15, 2014
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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