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Recently, osteoporosis has been recognized as a serious health problem in the elderly, it has also increased in young • middle-aged layer. Ginseng is history 2, 000 years Korean typical herbal medicine which is used as a medicinal is known the mystery of Elixir from a long time ago. A previous study was administered ginseng extract results in animal models induced osteoporosis, the bone-related biomarkers, including improved bone density and bone mass.
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ginseng extract on improvement of Bone metabolism in menopausal women. The investigators measured Serum Osteocalcin, Urinary Deoxypyridinoline, DPD/OC ratio, Serum CTX, NTX, Ca, Phosphorus, BSALP(vone specific-alkaline phosphatase), P1NP(Procollagen type 1 N-terminal propeptide), WOMAC index(Western Ontario and McMaster Universities Arthritis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginseng extract 1g | Experimental | Ginseng extract 1g |
|
| Ginseng extract 3g | Experimental | Ginseng extract 3g |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginseng extract 1g | Dietary Supplement | Ginseng extract 1g, parallel design |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum Osteocalcin | Serum Osteocalcin was measured in study baseline and visit 3(12 week). | Baseline and 12 week |
| Changes in Urinary Deoxypyridinoline | Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week). | Baseline and 12 week |
| Changes in DPD/OC ratio | DPD/OC ratio was measured in study baseline and visit 3(12 week) | Baseline and 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen) | Serum CTX was measured in study baseline and visit 3(12 week) | Baseline and 12 week |
| Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Ginseng extract 3g |
| Dietary Supplement |
Ginseng extract 3g, parallel design |
|
| Placebo | Dietary Supplement | placebo, parallel design |
|
Serum NTX was measured in study baseline and visit 3(12 week)
| Baseline and 12 week |
| Changes in Serum Ca, Phosphorus | Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week) | Baseline and 12 week |
| Changes in Serum BSALP(bone specific-alkaline phosphatase) | Serum BSALP was measured in study baseline and visit 3(12 week) | Baseline and 12 week |
| Changes in Serum P1NP(procollagen type 1 N-terminal propeptide) | Serum P1NP was measured in study baseline and visit 3(12 week) | Baseline and 12 week |
| Changes in WOMAC index(Western ontario and mcmaster universities arthritis) | WOMAC index was measured in study baseline and visit 3(12 week) | Baseline and 12 week |