Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
1 other identifier
interventional
100
1 country
1
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2017
CompletedFirst Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2018
CompletedDecember 19, 2019
December 1, 2019
1.1 years
March 9, 2017
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of Triglyceride
Changes of triglyceride were assessed before and after the intervention
12 weeks
Secondary Outcomes (2)
Changes of Lipid profile
12 weeks
Changes of Arteriosclerosis index
12 weeks
Study Arms (2)
Angelica gigas N. extract
EXPERIMENTALcapsules (2cap/d, 1,000mg/d) for 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks
Interventions
capsules (2cap/d, 1,000mg/d) for 12 weeks.
Eligibility Criteria
You may qualify if:
- Age 19-80 years with Triglyceride 130-200 mg/dL
You may not qualify if:
- Lipid lowering agent within past 6 months
- Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
- Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
- Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- Autoimmune disease
- Diabetes mellitus
- Allergic or hypersensitive to any of the ingredients in the test products
- History of disease that could interfere with the test products or impede their absorption
- Under antipsychotic drugs therapy within past 2 months
- History of alcohol or substance abuse
- Participation in any other clinical trials within past 2 months
- Laboratory test by show the following results
- aspartate aminotransferase, alanine aminotransferase \> Reference range upper limit treble
- Serum Creatinine \> 2.0 mg/dl
- Pregnancy or breast feeding
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 14, 2017
Study Start
March 2, 2017
Primary Completion
April 6, 2018
Study Completion
April 6, 2018
Last Updated
December 19, 2019
Record last verified: 2019-12