- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828188
Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 19-70 years with Triglyceride 120-200 mg/dL
Exclusion Criteria:
- Lipid lowering agent within past 6 months
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Persons with significant hypersensitivity reactions to ginseng and red ginseng
- Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
- Those who have received antipsychotic medication within 2 months before screening
- Those with a history of alcoholism or substance abuse
- Those who participated in other clinical trials within 2 months before screening
Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.
|
Placebo for 12 weeks.
Red Ginseng Concentrated Powder(4.9
g/day) for 12 weeks.
|
Experimental: group B
Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.
|
Placebo for 12 weeks.
Red Ginseng Concentrated Powder(4.9
g/day) for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Fasting triglyceride
Time Frame: 12 weeks
|
Changes of Fasting triglyceride was assessed before and after the intervention
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Lipid metabolism indices
Time Frame: 30 weeks
|
Lipid metabolism indices were assessed before and after the intervention. The lipid metabolism index should be measured by collecting blood while keeping fasting for 12 hours or more. The inspection items are as follows.
|
30 weeks
|
Changes of Arteriosclerosis indices
Time Frame: 30 weeks
|
It is calculated by the calculation formula using the lipid metabolism indicator test item. Round off the third decimal place to the second decimal place. The items are as follows: * Total cholesterol/HDL-C, LDL-C/HDL-C, triglycerid/HDL-C, (Total cholesterol - HDL-C)/HDL-C, Apo B/Apo A1 |
30 weeks
|
Changes of Carnitine (Serum)
Time Frame: 30 weeks
|
Carnitine (Serum)[μmol/L] was assessed before and after the intervention.
|
30 weeks
|
Changes of lipoprotein lipase
Time Frame: 30 weeks
|
lipoprotein lipase[ng/ml] was assessed before and after the intervention
|
30 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JAR-FHL-RG2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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