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Clinical Trials/NCT03828188
NCT03828188
Completed
Not Applicable

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

Chonbuk National University Hospital1 site in 1 country50 target enrollmentMarch 1, 2018
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ConditionsHyperlipidemias

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperlipidemias
Sponsor
Chonbuk National University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Changes of Fasting triglyceride
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.)

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
May 8, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Chonbuk National University Hospital

Eligibility 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

Outcomes

Primary Outcomes

Changes of Fasting triglyceride

Time Frame: 12 weeks

Changes of Fasting triglyceride was assessed before and after the intervention

Secondary Outcomes

  • Changes of Carnitine (Serum)(30 weeks)
  • Changes of lipoprotein lipase(30 weeks)
  • Changes of Lipid metabolism indices(30 weeks)
  • Changes of Arteriosclerosis indices(30 weeks)

Study Sites (1)

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