HyperlipidemiasNCT03079648
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
A study testing Angelica gigas N. extract in people with Hyperlipidemias, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Angelica gigas N. extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2017to 6 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-80 years with Triglyceride 130-200 mg/dL
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
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
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.
Read the 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.
- Conditions
- Hyperlipidemias
- Being tested
- Angelica gigas N. extract, Placebo
- Keywords
- Angelica gigas N. extract, Hyperlipidemia, Clinical Trial
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angelica gigas N. extractDietary supplement
capsules (2cap/d, 1,000mg/d) for 12 weeks.
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Angelica gigas N. extract | Experimental | capsules (2cap/d, 1,000mg/d) for 12 weeks. Receives: Dietary Supplement: Angelica gigas N. extract |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Triglyceride
Changes of triglyceride were assessed before and after the intervention
Measured: 12 weeks
Secondary outcomes (2)
Changes of Lipid profile
Changes of Lipid profile were assessed before and after the intervention
Measured: 12 weeks
Changes of Arteriosclerosis index
Changes of Arteriosclerosis index were assessed before and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start2 Mar 2017
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079648
- Sponsor's protocol ID
- WBP-HL-AG1
- Status last verified
- Dec 2019
- First submitted
- 9 Mar 2017
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03079648
- Acronym / sponsor ID
- WBP-HL-AG1
- Conditions
- Hyperlipidemias
- Keywords
- Angelica gigas N. extract, Hyperlipidemia, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angelica gigas N. extract | Experimental | Dietary Supplement: Angelica gigas N. extractcapsules (2cap/d, 1,000mg/d) for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-80 years with Triglyceride 130-200 mg/dL
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angelica gigas N. extractcapsules (2cap/d, 1,000mg/d) for 12 weeks. | Dietary supplement | Angelica gigas N. extract |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of Triglyceride
Time frame: 12 weeks
Changes of triglyceride were assessed before and after the intervention
2 secondary outcomes
Changes of Lipid profile
Time frame: 12 weeks
Changes of Arteriosclerosis index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angelica gigas N. extract in people with Hyperlipidemias, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Triglyceride (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.