Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Osteopenia

Intervention / Treatment
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* Dietary Supplement: Ginseng extract 1g
* Dietary Supplement: Ginseng extract 3g
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age older than 40 years, after a amenorrhea 6 months in women T-score less than -1.0, osteocalcin 8(ng/mL) or more and DPD 5.2(nMDPD/mMcreatinine) or more, subjects giving written informed consent Exclusion Criteria: Diagnosed osteoporosis BMI ≤ 18.5kg/m2 or BMI ≥ 30 kg/m2 Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnancy or breast feeding etc,.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginseng extract 1g<br>Ginseng extract 1g | Dietary Supplement: Ginseng extract 1g<br>* Ginseng extract 1g, parallel design<br>|
| Experimental: Ginseng extract 3g<br>Ginseng extract 3g | Dietary Supplement: Ginseng extract 3g<br>* Ginseng extract 3g, parallel design<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* placebo, parallel design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |