Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02138851
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2014-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Ficus Carica in Subjects With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in colon transit time', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in frequency of defecation', 'timeFrame': '8 week', 'description': 'Frequency of defecationI was measured in study baseline and visit 3(8 week).'}, {'measure': 'Changes in defecation time', 'timeFrame': '8 week', 'description': 'Defecation time was measured in study baseline and visit 3(8 week).'}, {'measure': 'Changes in stool type', 'timeFrame': '8 week', 'description': '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.'}, {'measure': 'Changes in abdominal discomfort', 'timeFrame': '8 week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Functional Constipation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 19 and 39 years,\n* diagnosis of functional constipation by ROME III criteria,\n* Colon transit time (CTT) ≥ 36 h,\n* subjects giving written informed consent\n\nExclusion Criteria:\n\n* allergic or hypersensitive response to any of the ingredients in the test products,\n* having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,\n* diagnosis of irritable bowel syndrome by ROME III criteria, etc,.'}, 'identificationModule': {'nctId': 'NCT02138851', 'briefTitle': 'The Effects of a Ficus Carica in Subjects With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica', 'orgStudyIdInfo': {'id': 'YGF-CON-FIG2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ficus Carica', 'description': 'Ficus Carica 300g/day', 'interventionNames': ['Dietary Supplement: Ficus Carica (300g/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 300g/day', 'interventionNames': ['Dietary Supplement: Placebo (300g/day)']}], 'interventions': [{'name': 'Ficus Carica (300g/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ficus Carica (300g/day), parallel design', 'armGroupLabels': ['Ficus Carica']}, {'name': 'Placebo (300g/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (300g/day), parallel design', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '561-712', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods; Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}