A clinical study with a purpose to determine whether administering fermented Korean red ginseng powder improves congnitive function and memory skills on people with mild cognitive impairment
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0000162
- Lead Sponsor
- Well-Being LS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Physically healthy men and women aged between 55 and 85 years old who complain of memory loss and demonstrate a decrease of 1.0 SD or more on CERAD-K (Consortium to Establish a Registry for Alzheimer's Disease-Korean version)
2. People who are able to read and sign an informed consent before participating in the study
1.People who are being hospitalized or within 3 months after hospital discharge for any types of malignant tumors, severe cardiovascular diseases (stroke, hemorrhage, etc), and sever heart diseases (angina, myocardial infarction, heart failure, arrhythmias requiring treatments). However, people who have a history of cardiovascular diseases but are clinically stable can participate in the study.
2.People who are currently suffering from schizophrenia or have a history of schizophrenia
3.People who have major depressive disorders categorized by DSM-IV
4.People who have poor cognitive function and have Alzheimer’s disease, Parkinson’s disease, or stroke. (The diagnosis of Alzheimer’s disease is based on DSM-IV)
5.People who have taken medications for Alzheimer’s disease or other cognitive function problems within 4 weeks prior to the first visit of the study. The examples of the medications are Antipsycotics, Neurodegenerative Disease Drugs, Nootropics & Neurotonics, and tricyclic antidepressant.
6.People with a daily intake of more than 400 IU vitamin E
7.People who have received estrogen replacement therapy within the first two months prior to the first visit of the study
8.People who have taken ginseng or red ginseng supplements for the purposes of improving cognitive function within the first two weeks prior to the first visit of the study
9.People with alcohol abuse or alcohol dependence
10.People with uncontrolled hypertension (170/100 mmHg or higher)
11.People with uncontrolled diabetes/blood sugar (fasting glucose of 180 mg/dl or higher)
12.People who have experienced side effects from taking ginseng or red ginseng products in the past
13.People with thyroid disease (TSH of 0.1 uU/ml or less, or TSH of 10 uU/ml or higher)
14.People with renal dysfunction whose creatinine level is more than twice the upper limit of normal range
15.People with dyshepatia or liver failure whose AST(GOT) or ALT(GPT) level is more than twice the upper limit of normal range
16.People who are pregnant or lactating women (for women who have a possibility of being pregnant, urine HCG test must be performed prior to the participation of the study)
17.People with any other health concerns
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the scores of ADAS-K between baseline and after 12 weeks of the treatment;Changes in the scores of Visual C.P.T between baseline and after 12 weeks of the treatment;Changes in the scores ADCS-ADL between baseline and after 12 weeks of the treatment;Changes in the scores of SGDS between baseline and after 12 weeks of the treatment
- Secondary Outcome Measures
Name Time Method adverse events;clinical pathological tests (hematologic test, blood chemical test, urine test), ;vital sign (blood pressure, pulse)