The effect of Korean red ginseng on glucose metabolism and diabetic complications in type 2 diabetes mellitus
| ISRCTN | ISRCTN17039603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17039603 |
| Secondary identifying numbers | 3-2015-0331 |
- Submission date
- 26/07/2017
- Registration date
- 05/09/2017
- Last edited
- 11/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
211, Yeongju-ro
Gangnam-gu
Seoul
06273
Korea, South
Scientific
211, Yeongju-ro
Gangnam-gu
Seoul
06273
Korea, South
Study information
| Study design | Single-center interventional double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of oral administration of red ginseng on glucose metabolism and diabetic complications in type 2 diabetic patients |
| Study hypothesis | Taking red ginseng in patients with type 2 diabetes will improve glucose metabolism and diabetic complications. |
| Ethics approval(s) | Gangnam Severance Hospital, 12/16/2015, ref: IRB 3-2015-0331 |
| Condition | Diabetes mellitus |
| Intervention | 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. |
| Intervention type | Supplement |
| 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 study start date | 02/03/2016 |
| Overall study end date | 02/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 83 |
| 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 |
| 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 | 07/03/2016 |
| Recruitment end date | 07/01/2017 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Korea, South
Sponsor information
Industry
71, Beotkkot-gil
Daedeok-gu
Daejeon
34337
Korea, South
| Website | https://www.kgc.co.kr |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in July 2018. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 11/12/2018 | 11/12/2018 | No | No | |
| Results article | 18/01/2020 | 11/10/2023 | Yes | No |
Additional files
- ISRCTN17039603_BasicResults_11Dec18.pdf
- Uploaded 11/12/2018
Editorial Notes
11/10/2023: Publication reference added.
11/12/2018: The basic results of this trial have been uploaded as an additional file.
