Efficacy and Safety of Angelica Gigas N. Extract on Impro... | NCT03079648

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

NCT03079648

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Dec 19, 2019Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Hyperlipidemias

Interventions

Angelica gigas N. extract
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2017Actual

Primary Completion Date

Apr 6, 2018Actual

Completion Date

Apr 6, 2018Actual

First Submitted Date

Mar 9, 2017

First Submission Date that Met QC Criteria

Mar 13, 2017

First Posted Date

Mar 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2019

Last Update Posted Date

Dec 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Angelica gigas N. extract	Experimental	capsules (2cap/d, 1,000mg/d) for 12 weeks.	Dietary Supplement: Angelica gigas N. extract
Placebo	Placebo Comparator	Placebo for 12 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angelica gigas N. extract	Dietary Supplement	capsules (2cap/d, 1,000mg/d) for 12 weeks.	Angelica gigas N. extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of Triglyceride	Changes of triglyceride were assessed before and after the intervention	12 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases