The Effects of a Ficus Carica in Subjects With Functional Constipation

NCT ID: NCT02138851

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ficus Carica

Ficus Carica 300g/day

Group Type EXPERIMENTAL

Ficus Carica (300g/day)

Intervention Type DIETARY_SUPPLEMENT

Ficus Carica (300g/day), parallel design

Placebo

Placebo 300g/day

Group Type PLACEBO_COMPARATOR

Placebo (300g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo (300g/day), parallel design

Interventions

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Ficus Carica (300g/day)

Ficus Carica (300g/day), parallel design

Intervention Type DIETARY_SUPPLEMENT

Placebo (300g/day)

Placebo (300g/day), parallel design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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,.
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YGF-CON-FIG2

Identifier Type: -

Identifier Source: org_study_id

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