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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Angelica gigas N. extract
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemias focused on measuring Angelica gigas N. extract, Hyperlipidemia, Clinical Trial

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angelica gigas N. extract

Placebo

Arm Description

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

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Changes of Triglyceride
Changes of triglyceride were assessed before and after the intervention

Secondary Outcome Measures

Changes of Lipid profile
Changes of Lipid profile were assessed before and after the intervention
Changes of Arteriosclerosis index
Changes of Arteriosclerosis index were assessed before and after the intervention

Full Information

First Posted
March 9, 2017
Last Updated
December 17, 2019
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03079648
Brief Title
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
April 6, 2018 (Actual)
Study Completion Date
April 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Angelica gigas N. extract, Hyperlipidemia, Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angelica gigas N. extract
Arm Type
Experimental
Arm Description
capsules (2cap/d, 1,000mg/d) for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Angelica gigas N. extract
Intervention Description
capsules (2cap/d, 1,000mg/d) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Primary Outcome Measure Information:
Title
Changes of Triglyceride
Description
Changes of triglyceride were assessed before and after the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes of Lipid profile
Description
Changes of Lipid profile were assessed before and after the intervention
Time Frame
12 weeks
Title
Changes of Arteriosclerosis index
Description
Changes of Arteriosclerosis index were assessed before and after the intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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