Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01911663
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2013-07-26
Brief Title:
The Effect of Korean Red Ginseng Supplementation on Glucose Control
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
The Effect of Korean Red Ginseng Supplementation on Glucose Control in Subjects With Impaired Fasting Glucose Impaired Glucose Tolerance or Newly-diagnosed Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized double-blind placebo-controlled clinical trial designed to evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with impaired fasting glucose impaired glucose tolerance or newly-diagnosed type 2 Diabetes Mellitus and to establish a clinical evidence on glucose control effect of KRG
Detailed Description:
Study participants who were all aged between 20 and 70 were recruited from health checkup center at Ilsan hospital Gyeonggi-do Korea and the advertisements in local newspaper After the glucose screening test subjects with IFG 100 mgdL fasting blood glucose 125mgdL IGT 140mgdL 2-h OGTT or newly-diagnosed T2DM fasting glucose 126 mgdL were enrolled in this study Exclusion criteria that all selected patients met were 1 Taking glucose-lowering medications or having insulin injections 2 Chronic alcoholism or having an evidence or alcoholism 3 Pregnant or in breast feeding 4 Having chronic gastrointestinal disorders 5 Showing signs of nutrient deficiency of malnutrition 6 Patients with serious kidney problems 7 Patients with serious liver problems 8 Patients whose job could be a threat when hypoglycemia occurs 9 Patients who have experienced the complications such as headache insomnia heart palpitations and raised blood pressure after eating red ginseng 10 Other patients who were considered unsuitable for this study by the researchers
This study was designed for 12-week randomized double-blinded placebo-controlled trial Sixty subjects were randomly assigned to receive placebo corn starch or 500 mg KRG Both group consumed 10 capsules per day three times daily after breakfast 3 capsules lunch 3 capsules and dinner 4 capsules and it comes to total 50g daily Red ginseng and placebo capsules were provided by the Korea Ginseng Cooperation KGC Daejeon Korea
Subjects met with the investigational team at four different time points Screening Week -1 randomization and treatment baseline Week 0 treatment midpoint Week 6 and treatment endpoint Week 12 Daily intake by 24-hour recall method and physical activity were measured at baseline Week 0 midpoint Week 6 and endpoint Week 12 of the treatment period Compliance with study restrictions and capsule consumption was monitored via daily documentation by subjects on individualized study calendars and end-study count of returned capsules
This study was designed for 12-week randomized double-blinded placebo-controlled trial Sixty subjects were randomly assigned to receive placebo corn starch or 500 mg KRG Both group consumed 10 capsules per day three times daily after breakfast 3 capsules lunch 3 capsules and dinner 4 capsules and it comes to total 50g daily Red ginseng and placebo capsules were provided by the Korea Ginseng Cooperation KGC Daejeon Korea
Subjects met with the investigational team at four different time points Screening Week -1 randomization and treatment baseline Week 0 treatment midpoint Week 6 and treatment endpoint Week 12 Daily intake by 24-hour recall method and physical activity were measured at baseline Week 0 midpoint Week 6 and endpoint Week 12 of the treatment period Compliance with study restrictions and capsule consumption was monitored via daily documentation by subjects on individualized study calendars and end-study count of returned capsules
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None