The Effects of a Ficus Carica in Subjects With Functional Constipation
|ClinicalTrials.gov Identifier: NCT02138851|
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Functional Constipation||Dietary Supplement: Ficus Carica (300g/day) Dietary Supplement: Placebo (300g/day)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Ficus Carica
Ficus Carica 300g/day
Dietary Supplement: Ficus Carica (300g/day)
Ficus Carica (300g/day), parallel design
Placebo Comparator: Placebo
Dietary Supplement: Placebo (300g/day)
Placebo (300g/day), parallel design
- Changes in colon transit time [ Time Frame: 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.
- Changes in frequency of defecation [ Time Frame: 8 week ]Frequency of defecationI was measured in study baseline and visit 3(8 week).
- Changes in defecation time [ Time Frame: 8 week ]Defecation time was measured in study baseline and visit 3(8 week).
- Changes in stool type [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138851
|Korea, Republic of|
|Clinical Trial Center for Functional Foods; Chonbuk National University Hospital|
|Jeonju, Jeollabuk-do, Korea, Republic of, 561-712|