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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ficus Carica | Experimental | Ficus Carica 300g/day |
|
| Placebo | Placebo Comparator | Placebo 300g/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ficus Carica (300g/day) | Dietary Supplement | Ficus Carica (300g/day), parallel design |
| |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 561-712 | South Korea |
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| Placebo (300g/day) |
| Dietary Supplement |
Placebo (300g/day), parallel design |
|
| 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 |