HyperglycemiaNCT03258229
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
A study testing Angelica gigas N. extract in people with Hyperglycemia, 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 Hyperglycemia . Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- 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
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2017to 7 Dec 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl
Who cannot join
- Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks
- Treated with corticosteroid within past 4 weeks
- Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
- Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
- Rheumatoid arthritis, Autoimmune disease
Show all 17Show fewer
- Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- 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 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Hyperglycemia .
Read the detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
- Conditions
- Hyperglycemia
- Being tested
- Angelica gigas N. extract, Placebo
- Keywords
- Angelica gigas N. extract, Glucose, Clinical Trial
- Medical subject headings
- Hyperglycemia
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 8 weeks.
PlaceboDietary supplement
Placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Angelica gigas N. extract | Experimental | capsules(2cap/d, 1,000mg/d) for 8 weeks. Receives: Dietary Supplement: Angelica gigas N. extract |
| Placebo | Placebo comparator | Placebo for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose during OGTT (oral glucose tolerance test)
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Measured: 8 weeks
Secondary outcomes (6)
Changes of blood insulin during OGTT
Changes of blood insulin during OGTT were assessed before and after the intervention.
Measured: 8 weeks
Changes of Homeostatic model assessment-insulin resistance
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention
Measured: 8 weeks
Changes of Homeostatic model assessment-beta-cell
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Measured: 8 weeks
Changes of HbA1c
Changes of HbA1c(%) were assessed before and after the intervention
Measured: 8 weeks
Changes of Adiponectin, Leptin
Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention
Measured: 8 weeks
Changes of lipid profile
Changes of lipid profile were assessed before and after the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start9 Feb 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Crossover
- Model description
- 2×2 cross-over Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT03258229
- Sponsor's protocol ID
- WBP-HG-AG2
- Status last verified
- Aug 2019
- First submitted
- 9 Mar 2017
- Last updated
- 22 Aug 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 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
- ClinicalTrials.gov ID
- NCT03258229
- Acronym / sponsor ID
- WBP-HG-AG2
- Conditions
- Hyperglycemia
- Keywords
- Angelica gigas N. extract, Glucose, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 23 Aug 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 Hyperglycemia .
Detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2×2 cross-over Assignment
| Arm | Type | Receives |
|---|---|---|
| Angelica gigas N. extract | Experimental | Dietary Supplement: Angelica gigas N. extractcapsules(2cap/d, 1,000mg/d) for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 8 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl
Key exclusion criteria (17 listed)
- Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks
- Treated with corticosteroid within past 4 weeks
- Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
- Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
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 8 weeks. | Dietary supplement | Angelica gigas N. extract |
| PlaceboPlacebo for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of blood glucose during OGTT (oral glucose tolerance test)
Time frame: 8 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
6 secondary outcomes
Changes of blood insulin during OGTT
Time frame: 8 weeks
Changes of Homeostatic model assessment-insulin resistance
Time frame: 8 weeks
Changes of Homeostatic model assessment-beta-cell
Time frame: 8 weeks
Changes of HbA1c
Time frame: 8 weeks
Changes of Adiponectin, Leptin
Time frame: 8 weeks
Changes of lipid profile
Time frame: 8 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 22 Aug 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 Hyperglycemia, 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 17 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 22 Aug 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 blood glucose during OGTT (oral glucose tolerance test) (time frame: 8 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 22 Aug 2019.