Functional Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFicus Carica (300g/day)
Ficus Carica (300g/day), parallel design
DIETARY_SUPPLEMENTPlacebo (300g/day)
Placebo (300g/day), parallel design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 39 Years
Healthy volunteers
Yes
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,.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in colon transit time | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in frequency of defecation | 8 week | Frequency of defecationI was measured in study baseline and visit 3(8 week). |
| Changes in defecation time | 8 week | Defecation time was measured in study baseline and visit 3(8 week). |
| Changes in stool type | 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. |
| Changes in abdominal discomfort | 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. |
Countries
South Korea
Outcome results
None listed