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| Name | Class |
|---|---|
| Kyunghee University | OTHER |
| HK inno.N Corporation | INDUSTRY |
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This is a placebo-controlled, randomized, double-blind, multiple dose study that evaluated the safety, tolerability, and changes in indicators of immune function of Korean Red Ginseng Extract in Vietnamese healthy subjects following oral administration of multiple dose of Korean Red Ginseng Extract as hard capsules or placebo to healthy adult men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRG hard capsules | Active Comparator | Each KRG hard capsule contains 500 mg of red ginseng extract. Dosage of KRG hard capsule: oral administration of 1 capsule twice daily for 12 weeks. |
|
| Placebo hard capsules | Placebo Comparator | The composition of the Placebo hard capsule contains red ginseng flavor. Dosage of Placebo hard capsule: oral administration of 1 capsule twice daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRG hard capsule | Drug | Each subject was given orally 2 KRG hard capsules/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events associated with the administration of KRG | Frequency and characteristics of adverse events associated with the administration of KRG | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Natural killer (NK) cell count | Change in NK cell count after 12 weeks compared to baseline | 12 weeks |
| White blood cell count | Change in white blood cell count after 12 weeks compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Clinical Pharmacology | Hanoi | Vietnam |
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| Placebo hard capsule | Drug | Each subject was given orally 2 placebo hard capsules/day for 12 weeks |
|
| 12 weeks |
| Interferon (IFN)-α, β, γ levels | Changes in IFN-α, β, γ levels after 12 weeks compared to baseline | 12 weeks |
| Tumor necrosis factor (TNF)-α, β, γ levels | Changes in TNF-α, β, γ levels after 12 weeks compared to baseline | 12 weeks |
| Interleukin (IL)-1, 4, 6 levels | Changes in IL-1, 4, 6 levels after 12 weeks compared to baseline | 12 weeks |