Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/07/2017
Date assigned
05/09/2017
Last edited
24/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jisun Nam

ORCID ID

Contact details

211
Yeongju-ro
Gangnam-gu
Seoul
06273
Korea
South

Type

Scientific

Additional contact

Dr Chul Woo Ahn

ORCID ID

Contact details

211
Yeongju-ro
Gangnam-gu
Seoul
06273
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3-2015-0331

Study information

Scientific title

Effect of oral administration of red ginseng on glucose metabolism and diabetic complications in type 2 diabetic patients

Acronym

Study hypothesis

Taking red ginseng in patients with type 2 diabetes will improve glucose metabolism and diabetic complications.

Ethics approval

Gangnam Severance Hospital, 12/16/2015, ref: IRB 3-2015-0331

Study design

Single-center interventional double-blind randomized placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

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

Phase

Drug names

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

02/03/2016

Overall trial end date

02/08/2017

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

83

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

Trial participating centre

Gangnam Severance Hospital
06273

Sponsor information

Organisation

Korea Ginseng Corporation

Sponsor details

71
Beotkkot-gil
Daedeok-gu
Daejeon
34337
Korea
South

Sponsor type

Industry

Website

https://www.kgc.co.kr

Funders

Funder type

Industry

Funder name

Korea Ginseng Corporation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/07/2018

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes