Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
NCT ID: NCT04023864
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2018-10-19
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Platycodon Grandiflorus Extract(GCWB107) group
Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107))
Platycodon Grandiflorus Extract(GCWB107)
Once-daily, once a tablet, after meals, for 12 week
Placebo group
Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107))
Placebo
Placebo for 12 week
Interventions
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Platycodon Grandiflorus Extract(GCWB107)
Once-daily, once a tablet, after meals, for 12 week
Placebo
Placebo for 12 week
Eligibility Criteria
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Inclusion Criteria
* Participants who were BMI 25\~29.9 kg/m\^2
* Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Exclusion Criteria
* Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)
* Participants who drink more than 14 units/week of alcohol intake
* Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic
* Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)
* Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
* Participants who have a history of clinically significant hypersensitivity to balloon flower and saponin components
* Participants receiving antipsychotic medication within 2 months prior to the screening examination
* Participants who were doubtful about drug abuse
* Participants who have participated in other clinical trials within 3 months prior to the screening examination
* Participants who have SBP≥180 mmHg and DBP≥110 mmHg
* Menopause women
* Participants who show the following relevant results in a Laboratory test
* Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dl
* Women who are pregnant or breastfeeding
* Women who may become pregnant and have not used appropriate contraceptives
* Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
19 Years
65 Years
ALL
Yes
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GCWB-BF-PG
Identifier Type: -
Identifier Source: org_study_id
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