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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteopenia
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Changes in Serum Osteocalcin
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Soo-Wan Chae
principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
Eligibility Criteria
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,.
Outcomes
Primary Outcomes
Changes in Serum Osteocalcin
Time Frame: Baseline and 12 week
Serum Osteocalcin was measured in study baseline and visit 3(12 week).
Changes in Urinary Deoxypyridinoline
Time Frame: Baseline and 12 week
Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).
Changes in DPD/OC ratio
Time Frame: Baseline and 12 week
DPD/OC ratio was measured in study baseline and visit 3(12 week)
Secondary Outcomes
- Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)(Baseline and 12 week)
- Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)(Baseline and 12 week)
- Changes in Serum Ca, Phosphorus(Baseline and 12 week)
- Changes in Serum BSALP(bone specific-alkaline phosphatase)(Baseline and 12 week)
- Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)(Baseline and 12 week)
- Changes in WOMAC index(Western ontario and mcmaster universities arthritis)(Baseline and 12 week)