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

Chonbuk National University

Status: Completed

Conditions: Hyperlipidemias

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Red Ginseng Concentrated Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03828188

JAR-FHL-RG2

Details and patient eligibility

About

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

Full 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.)

Enrollment: 50 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

group A

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Red Ginseng Concentrated Powder

group B

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Red Ginseng Concentrated Powder