Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

Chonbuk National University

Status: Completed

Conditions: Hyperglycemia

Treatments: Dietary Supplement: Angelica gigas N. extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03258229

WBP-HG-AG2

Details and patient eligibility

About

This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Hyperglycemia .

Full description

This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl

Exclusion criteria

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

• Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks

• Treated with corticosteroid within past 4 weeks

• Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)

• Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)

• Rheumatoid arthritis, Autoimmune disease

• Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)

• Allergic or hypersensitive to any of the ingredients in the test products

• History of disease that could interfere with the test products or impede their absorption

• Under antipsychotic drugs 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 upper limit treble
  • Serum Creatinine > 2.0 mg/dl

• Pregnancy or breast feeding

• Not Contraception(except: Surgery for female infertility)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Angelica gigas N. extract

Experimental group

Description:

capsules(2cap/d, 1,000mg/d) for 8 weeks.

Treatment:

Dietary Supplement: Angelica gigas N. extract

Placebo

Placebo Comparator group

Description:

Placebo for 8 weeks

Treatment:

Dietary Supplement: Placebo