Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride

Study Overview
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Brief Summary
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This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.

Detailed Description
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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting triglyceride profiles before and after the intervention.

Official Title
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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

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: Angelica gigas N. extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19-80 years with Triglyceride 130-200 mg/dL Exclusion Criteria: 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 Not Contraception(except: Surgery for female infertility)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angelica gigas N. extract<br>capsules (2cap/d, 1,000mg/d) for 12 weeks. | Dietary Supplement: Angelica gigas N. extract<br>* capsules (2cap/d, 1,000mg/d) for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks | Dietary Supplement: Placebo<br>* Placebo for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Triglyceride | Changes of triglyceride were assessed before and after the intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Lipid profile | Changes of Lipid profile were assessed before and after the intervention | 12 weeks | 
| Changes of Arteriosclerosis index | Changes of Arteriosclerosis index were assessed before and after the intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angelica gigas N. extract, Hyperlipidemia, Clinical Trial