Plain English Summary
Background and study aims
Red ginseng is a herbal medicine that has been used for a long time. It is known to have various effects on the central nervous system, cardiovascular system, endocrine system and immune system. Among them, various studies have revealed that red ginseng has an effect on blood vessels and thus has a good effect on arteriosclerosis (the thickening and hardening of the walls of the arteries) and lowering blood glucose. The aim of this study is to investigate the effects of red ginseng on oxidative stress and end glycation products, which are known to play a major role in diabetic complications.
Who can participate?
Patients between 19 and 75 years of age with type 2 diabetes
What does the study involve?
Participants are randomly allocated to receive either Korean red ginseng capsules or placebo (dummy) capsules. They are instructed to take two tablets twice a day for 24 weeks. No other medication is prescribed and the participants’ original diabetes medication is not changed. Blood glucose levels and markers of diabetic complications are measured after 24 weeks.
What are the possible benefits and risks of participating?
During the study period, red ginseng tablets and tests for glucose metabolism and diabetes complications are provided free of charge. The risk is low because red ginseng is already approved as a health functional food and a commercially available medicine.
Where is the study run from?
Gangnam Severance Hospital (South Korea)
When is the study starting and how long is it expected to run for?
March 2016 to August 2017
Who is funding the study?
Korea Ginseng Corporation (South Korea)
Who is the main contact?
1. Dr Jisun Nam
2. Dr Chul Woo Ahn
Effect of oral administration of red ginseng on glucose metabolism and diabetic complications in type 2 diabetic patients
Taking red ginseng in patients with type 2 diabetes will improve glucose metabolism and diabetic complications.
Gangnam Severance Hospital, 12/16/2015, ref: IRB 3-2015-0331
Single-center interventional double-blind randomized placebo-controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
No participant information sheet available
Enrolled subjects were randomized using a computer generated randomization table. Subjects were randomized to receive Korean red ginseng capsules or placebos for 24 weeks. They were instructed to take two tablets of Korean red ginseng or placebo twice a day (taking total 2 grams a day). No other medication was prescribed and the patients’ original diabetes medication remained unchanged.
Primary outcome measure
Diabetic microvascular complication markers (estimated glomerular filtration rate (eGFR), urinary albumin to creatinine ratio (uACR), Kidney injury molecule-1 (KIM1), laminin-P1 as a marker for diabetic retinopathy, and current perception thresholds (CPT)), measured at week 24
Secondary outcome measures
Fasting plasma glucose and HbA1c, measured by blood test at week 24
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Men and women between 19 and 75 years of age with Type 2 diabetes on oral antidiabetic agents
2. Diagnosed with Type 2 diabetes more than 6 months ago
3. Unchanged dose or type of antidiabetic agents within the last 3 months
Target number of participants
Participant exclusion criteria
1. Patients with HbA1c>10%
2. Patients with eGFR < 30 mL/min/1.73 m2, AST/ALT > 3 times greater the upper normal limit
3. Taking glucocorticoid or any herbal medicine within the past 3 months
4. Chronic inflammatory disease in the active phase or acute infection status
5. Pregnant or lactating women
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Gangnam Severance Hospital
Korea Ginseng Corporation
Korea Ginseng Corporation
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in July 2018.
IPD sharing statement
All data collected for clinical research will be stored on a computer with limited access to which the subject identification information is coded, the stored data will be kept secure and a safety check will be made by the researcher.
Intention to publish date
Participant level data
Basic results (scientific)
See additional file (ISRCTN17039603_BasicResults_11Dec18.pdf)
- ISRCTN17039603_BasicResults_11Dec18.pdf Uploaded 11/12/2018