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

Hyperlipidemias Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079648
• Other study ID #: WBP-HL-AG1
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: April 6, 2018

Study information

• Verified date: December 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Angelica gigas N. extract
capsules (2cap/d, 1,000mg/d) for 12 weeks.
• Placebo
Placebo for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Triglyceride	Changes of triglyceride were assessed before and after the intervention	12 weeks
Secondary	Changes of Lipid profile	Changes of Lipid profile were assessed before and after the intervention	12 weeks
Secondary	Changes of Arteriosclerosis index	Changes of Arteriosclerosis index were assessed before and after the intervention	12 weeks