Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

Chonbuk National University

Status: Unknown

Conditions: Hyperglycemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Hydrolysed Red Ginseng Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT03775733

GH-HG-HR

Details and patient eligibility

About

This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

Full description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19-80 years with fasting glucose 100-140 mg/dL

Exclusion criteria

• Weight less than 48 kg or weight decreased by more than 10% within past 3 months

• Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.

• Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months

• Blood sugar improvement or healthy functional food within past 1 month

• Under antipsychotic medication therapy within past 2 months

• History of alcohol or substance abuse

• Participation in any other clinical trials within past 2 months

• Laboratory test by show the following results

  • aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit
  • Serum Creatinine > 2.0 mg/dl

• Pregnancy or breast feeding

• If a woman of childbearing doesn't accept the implementation of appropriate contraception

• Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Hydrolysed red ginseng extract

Experimental group

Description:

Hydrolysed red ginseng extract 2.4g/day for 12 weeks

Treatment:

Dietary Supplement: Hydrolysed Red Ginseng Extract

Placebo

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo