Back to resultsSafety for 24 Weeks Intake of Korean Red Ginseng in Adults
Primary Purpose
Healthy, Diabetes, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- 19 years or older
- agree to participate in this test, voluntarily signed by the parties to a written agreement
- In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
Exclusion Criteria:
- Pregnant and lactating mothers
- Patients with a history of hypersensitivity to contain ingredients that caused the test food
- patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
- Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
- autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
- patients with uncontrolled diabetes (for HbA1c 8.0% or more)
- Sulphonylureas, diabetic patients being treated with Insulin
- , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
- uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
- patients with uncontrolled thyroid dysfunction
- patients with a dementia or psychiatric problems
- treated with systemic steroid screening visit within 1 weeks ago
- before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
- taking the medicine within 4 weeks before the screening visit
- taking the other investigational drugs or human test food application within four weeks before the screening visit
- taking health supplements other than vitamins and minerals within 2 weeks before randomization
- which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
Sites / Locations
- Catholic Universtiy of Korea. Seoul St Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Korean Red Ginseng
Placebo
Arm Description
Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses
Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses
Outcomes
Primary Outcome Measures
All adverse events occurring up to 24 weeks time after taking the Investigational product
Secondary Outcome Measures
Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product
Cardiovascular adverse events that occurred after taking the Investigational product
Gastrointestinal adverse events that occurred after ingestion of Investigational product
Neuropsychiatric adverse events that occurred after ingestion of Investigational product
Grade 3 adverse events that occurred after ingestion of Investigational product
Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product
Full Information
NCT ID
NCT02428998
First Posted
April 20, 2015
Last Updated
August 9, 2017
Sponsor
Korea Ginseng Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02428998
Brief Title
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
Official Title
Safety Evaluation for 24 Weeks Intake of Korean Red Ginseng in Adults: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Exploratory Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Ginseng Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Diabetes, Hypertension, Hyperlipidemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Korean Red Ginseng
Arm Type
Experimental
Arm Description
Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses
Intervention Type
Dietary Supplement
Intervention Name(s)
Korean Red Ginseng
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
All adverse events occurring up to 24 weeks time after taking the Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Secondary Outcome Measure Information:
Title
Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product
Time Frame
up to 24 weeks to collect all focus point after taking the Investigational product
Title
Cardiovascular adverse events that occurred after taking the Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Title
Gastrointestinal adverse events that occurred after ingestion of Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Title
Neuropsychiatric adverse events that occurred after ingestion of Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Title
Grade 3 adverse events that occurred after ingestion of Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Title
Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product
Time Frame
up to 24 weeks time after taking the Investigational product
Other Pre-specified Outcome Measures:
Title
glucose, insulin, HbA1c levels, HOMA-IR index variation
Time Frame
up to 24 weeks time after taking the Investigational product
Title
BMI, waist circumference variation
Time Frame
up to 24 weeks time after taking the Investigational product
Title
adiponectin, leptin levels of variation
Time Frame
up to 24 weeks time after taking the Investigational product
Title
URTI (Upper respiratory tract infection) rates
Time Frame
up to 24 weeks time after taking the Investigational product
Title
hs-CRP, IL-6, homocysteine concentration of variation
Time Frame
up to 24 weeks time after taking the Investigational product
Title
eGFR, change amount of urine protein
Time Frame
up to 24 weeks time after taking the Investigational product
Title
Variation of CFS (Chalder fatigue scale)
Time Frame
up to 24 weeks time after taking the Investigational product
Title
variation of biological age
Time Frame
up to 24 weeks time after taking the Investigational product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
19 years or older
agree to participate in this test, voluntarily signed by the parties to a written agreement
In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
Exclusion Criteria:
Pregnant and lactating mothers
Patients with a history of hypersensitivity to contain ingredients that caused the test food
patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
patients with uncontrolled diabetes (for HbA1c 8.0% or more)
Sulphonylureas, diabetic patients being treated with Insulin
, uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
patients with uncontrolled thyroid dysfunction
patients with a dementia or psychiatric problems
treated with systemic steroid screening visit within 1 weeks ago
before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
taking the medicine within 4 weeks before the screening visit
taking the other investigational drugs or human test food application within four weeks before the screening visit
taking health supplements other than vitamins and minerals within 2 weeks before randomization
which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungsoo Kim, M.D., Ph.D
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic Universtiy of Korea. Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
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Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
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