The Effects of a Ficus Carica in Subjects With Functional Constipation

Study Overview
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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.

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

Conditions
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Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Ficus Carica (300g/day)
* Dietary Supplement: Placebo (300g/day)


Participation Criteria
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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,.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ficus Carica<br>Ficus Carica 300g/day | Dietary Supplement: Ficus Carica (300g/day)<br>* Ficus Carica (300g/day), parallel design<br>|
| Placebo Comparator: Placebo<br>Placebo 300g/day | Dietary Supplement: Placebo (300g/day)<br>* Placebo (300g/day), parallel design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in frequency of defecation | Frequency of defecationI was measured in study baseline and visit 3(8 week). | 8 week | 
| Changes in defecation time | Defecation time was measured in study baseline and visit 3(8 week). | 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. | 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. | 8 week |