The Effects of a Ficus Carica in Subjects With Functional Constipation
Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedMay 16, 2016
May 1, 2016
Same day
May 13, 2014
May 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (4)
Changes in frequency of defecation
8 week
Changes in defecation time
8 week
Changes in stool type
8 week
Changes in abdominal discomfort
8 week
Study Arms (2)
Ficus Carica
EXPERIMENTALFicus Carica 300g/day
Placebo
PLACEBO COMPARATORPlacebo 300g/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
May 16, 2016
Record last verified: 2016-05