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

December 17, 2019 updated by: Soo-Wan Chae, Chonbuk National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo for 12 weeks
Dietary supplement: Placebo
Placebo for 12 weeks
EXPERIMENTAL: Angelica gigas N. extract
capsules (2cap/d, 1,000mg/d) for 12 weeks.
Dietary supplement: Angelica gigas N. extract
capsules (2cap/d, 1,000mg/d) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2017

Primary Completion (ACTUAL)

April 6, 2018

Study Completion (ACTUAL)

April 6, 2018

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (ACTUAL)

March 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBP-HL-AG1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperlipidemias

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe