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

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ClinicalTrials.gov Identifier: NCT03828188
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
Hyperlipidemias Dietary Supplement: Red Ginseng Concentrated Powder Dietary Supplement: Placebo Not Applicable

Detailed 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.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: group A

Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.

  • Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
  • Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
Dietary Supplement: Red Ginseng Concentrated Powder
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

Dietary Supplement: Placebo
Placebo for 12 weeks.

Experimental: group B

Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.

  • Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
  • Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
Dietary Supplement: Red Ginseng Concentrated Powder
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

Dietary Supplement: Placebo
Placebo for 12 weeks.




Primary Outcome Measures :
  1. Changes of Fasting triglyceride [ Time Frame: 12 weeks ]
    Changes of Fasting triglyceride was assessed before and after the intervention


Secondary Outcome Measures :
  1. 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.

    • 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)

  2. 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


  3. Changes of Carnitine (Serum) [ Time Frame: 30 weeks ]
    Carnitine (Serum)[μmol/L] was assessed before and after the intervention.

  4. Changes of lipoprotein lipase [ Time Frame: 30 weeks ]
    lipoprotein lipase[ng/ml] was assessed before and after the intervention



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828188


Contacts
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Contact: Soo Wan Chae, Ph.D., M.D. 82-63-259-3040 soowan@jbnu.ac.kr

Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Soo-Wan Chae, MD., PhD    82-63-259-3040    swchae@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital

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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03828188     History of Changes
Other Study ID Numbers: JAR-FHL-RG2
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Red Ginseng Concentrated Powder
Hyperlipidemias
Clinical Trial

Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases