Osteopenia
Conditions
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTGinseng extract 1g
Ginseng extract 1g, parallel design
DIETARY_SUPPLEMENTGinseng extract 3g
Ginseng extract 3g, parallel design
DIETARY_SUPPLEMENTPlacebo
placebo, parallel design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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,.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Serum Osteocalcin | Baseline and 12 week | Serum Osteocalcin was measured in study baseline and visit 3(12 week). |
| Changes in Urinary Deoxypyridinoline | Baseline and 12 week | Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week). |
| Changes in DPD/OC ratio | Baseline and 12 week | DPD/OC ratio was measured in study baseline and visit 3(12 week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Serum BSALP(bone specific-alkaline phosphatase) | Baseline and 12 week | Serum BSALP was measured in study baseline and visit 3(12 week) |
| Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen) | Baseline and 12 week | Serum CTX was measured in study baseline and visit 3(12 week) |
| Changes in WOMAC index(Western ontario and mcmaster universities arthritis) | Baseline and 12 week | WOMAC index was measured in study baseline and visit 3(12 week) |
| Changes in Serum P1NP(procollagen type 1 N-terminal propeptide) | Baseline and 12 week | Serum P1NP was measured in study baseline and visit 3(12 week) |
| Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen) | Baseline and 12 week | Serum NTX was measured in study baseline and visit 3(12 week) |
| Changes in Serum Ca, Phosphorus | Baseline and 12 week | Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week) |
Countries
South Korea
Outcome results
None listed