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

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Angelica gigas N. extract

• Registration Number: NCT03079648
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-14
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 12 weeks
Angelica gigas N. extract	Angelica gigas N. extract	capsules (2cap/d, 1,000mg/d) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Changes of Triglyceride	12 weeks	Changes of triglyceride were assessed before and after the intervention

Secondary Outcome Measures

Name	Time	Method
Changes of Lipid profile	12 weeks	Changes of Lipid profile were assessed before and after the intervention
Changes of Arteriosclerosis index	12 weeks	Changes of Arteriosclerosis index were assessed before and after the intervention

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of