Study on the Effects of Oral Administration of the Korean Red Ginseng on Clinical Parameters of Glycemic Control, Diabetic Complications and Safety among Type 2 Diabetes Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011311

Enrollment

Registered

2025-12-11

Start date

2023-05-11

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : KRG group: Korean Red Ginseng tablets(500 mg per tablet

two tablets per dose, twice daily) for a duration of 12 weeks

Placebo Control Group: Placebo tablets (500 mg per tablet

two tablets per dose, twice daily) for a duration of 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants were eligible for inclusion if they were adults aged 19 to 75 years with a confirmed diagnosis of T2DM of less than 15 years’ duration and well-controlled glycemic status, defined as 1) an HbA1c level below 7.5%; 2) no use of exogenous insulin; 3) use of no more than two oral glucose-lowering agents; and 4) no changes in prescribed antidiabetic medications within the previous six months.

Exclusion criteria

Exclusion criteria: Participants were excluded if 1) they had regularly consumed any type of herbal supplements within the preceding six months; 2) had a history of malignancy; 3) were pregnant or breastfeeding at the time of enrollment; or 4) had undergone major surgery within the past year.

Design outcomes

Primary

Measure	Time frame
Insulin Sensitivity Indices [Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Updated Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), Updated Homeostasis Model Assessment of Insulin Sensitivity Percentage (HOMA2-%S), Quantitative Insulin Sensitivity Check Index (QUICKI), Insulin Sensitivity Index derived from OGTT (ISI0–120), Stumvoll Insulin Sensitivity Index, Avignon Insulin Sensitivity Index, Matsuda Index] ;ß-cell Function Indices [Homeostasis Model Assessment of ß-cell Function (HOMA-ß), Updated Homeostasis Model Assessment of ß-cell Function (HOMA2-ß), Insulinogenic Index (IGI), C-Peptide to Glucose Ratio Index (CPRI), Disposition Index (DI)] ;Oxidative stress markers [oidized LDL (oxLDL), protein carbonyls (PC), Advanced Oxidation Protein Products (AOPPs), Malondialdehyde (MDA)];Serum Antioxidant Capacity [Oxygen Radical Absorbance Capacity (ORAC), Trolox Equivalent Antioxidant Capacity (TEAC), Ferric Reducing Antioxidant Power (FRAP)];Renal Function Parameters [Blood Urea Nitrogen (BUN), Serum Creatinine, Estimated Glomerular Filtration Rate (eGFR) by MDRD and CKD-EPI equations, Urinary Albumin-to-Creatinine Ratio (ACR), Urinary Kidney Injury Molecule-1 (KIM-1)];Hepatic Function Parameters [Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Serum Albumin];Hypoglycemic Events (Symptomatic or Asymptomatic Hypoglycemia);Glycated hemoglobin (HbA1c);Fasting plasma glucose (FPG), insulin (FPI), C-peptide (FcP), Glucagon (FPGc);Dynamic changes in insulin, C-peptide, and glucagon levels during 75g 2-hour oral glucose tolerance test (OGTT)	—

Measure

Time frame

Insulin Sensitivity Indices [Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Updated Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), Updated Homeostasis Model Assessment of Insulin Sensitivity Percentage (HOMA2-%S), Quantitative Insulin Sensitivity Check Index (QUICKI), Insulin Sensitivity Index derived from OGTT (ISI0–120), Stumvoll Insulin Sensitivity Index, Avignon Insulin Sensitivity Index, Matsuda Index] ;ß-cell Function Indices [Homeostasis Model Assessment of ß-cell Function (HOMA-ß), Updated Homeostasis Model Assessment of ß-cell Function (HOMA2-ß), Insulinogenic Index (IGI), C-Peptide to Glucose Ratio Index (CPRI), Disposition Index (DI)] ;Oxidative stress markers [oidized LDL (oxLDL), protein carbonyls (PC), Advanced Oxidation Protein Products (AOPPs), Malondialdehyde (MDA)];Serum Antioxidant Capacity [Oxygen Radical Absorbance Capacity (ORAC), Trolox Equivalent Antioxidant Capacity (TEAC), Ferric Reducing Antioxidant Power (FRAP)];Renal Function Parameters [Blood Urea Nitrogen (BUN), Serum Creatinine, Estimated Glomerular Filtration Rate (eGFR) by MDRD and CKD-EPI equations, Urinary Albumin-to-Creatinine Ratio (ACR), Urinary Kidney Injury Molecule-1 (KIM-1)];Hepatic Function Parameters [Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Serum Albumin];Hypoglycemic Events (Symptomatic or Asymptomatic Hypoglycemia);Glycated hemoglobin (HbA1c);Fasting plasma glucose (FPG), insulin (FPI), C-peptide (FcP), Glucagon (FPGc);Dynamic changes in insulin, C-peptide, and glucagon levels during 75g 2-hour oral glucose tolerance test (OGTT)

—

Secondary

Measure	Time frame
Lipid profile parameters [Total Cholesterol (TC, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG)];Anthropometry Measures [body weight (BW), Body Mass Index (BMI), Waist Circumference (WC)	—

Countries

Korea, Republic of

Contacts

Public ContactYuSik Kim

Yonsei University Health System, Gangnam Severance Hospital

cromoton@yuhs.ac+82-2-2019-5331

Outcome results