Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828188
• Other study ID #: JAR-FHL-RG2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 8, 2019

Study information

• Verified date: May 2020
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

Description:

This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 8, 2019
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Red Ginseng Concentrated Powder
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
• Placebo
Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Fasting triglyceride	Changes of Fasting triglyceride was assessed before and after the intervention	12 weeks
Secondary	Changes of Lipid metabolism indices	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.; Total cholesterol, triglyceride, LDL-C, HDL-C, Non HDL-C, VLDL-C, free fatty acid, Apo A1, Apo B, hs-CRP; Non HDL-C and VLDL-C are calculated by the calculation formula, and the first digit of the decimal point is indicated.; Non HDL-C= Total cholesterol - HDL-C VLDL-C= Total cholesterol - (HDL-C + LDL-C)	30 weeks
Secondary	Changes of Arteriosclerosis indices	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
Secondary	Changes of Carnitine (Serum)	Carnitine (Serum)[µmol/L] was assessed before and after the intervention.	30 weeks
Secondary	Changes of lipoprotein lipase	lipoprotein lipase[ng/ml] was assessed before and after the intervention	30 weeks