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Completed

NCT Number: NCT03079648

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

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

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Angelica gigas N. extract

Dietary Supplement

capsules (2cap/d, 1,000mg/d) for 12 weeks.

Placebo

Dietary Supplement

Placebo for 12 weeks

Primary outcomes

  1. Changes of Triglyceride

    Time frame: 12 weeks

    Changes of triglyceride were assessed before and after the intervention

Secondary outcomes

  1. Changes of Lipid profile

    Time frame: 12 weeks

    Changes of Lipid profile were assessed before and after the intervention

  2. Changes of Arteriosclerosis index

    Time frame: 12 weeks

    Changes of Arteriosclerosis index were assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2017
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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