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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

Effects of fermented Korean red ginseng powder on the mild cognitive impairment for the efficacy and safety; a 12-week, multi-center, randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0000162
Enrollment
80
Registered
2011-08-05
Start date
2011-05-31
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The subjects in experimental group orally take the fermented Korean red ginseng powder 3 times a day, 2 capsules at a time, for 12 weeks. One capsule contains 405mg of fermented

Sponsors

Well-Being LS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
adverse events;clinical pathological tests (hematologic test, blood chemical test, urine test), ;vital sign (blood pressure, pulse)

Countries

Korea, Republic of

Contacts

Public ContactJae Nam Bae

Inha University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026