Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women
- Conditions
- Osteopenia
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Ginseng extract 1gDietary Supplement: Ginseng extract 3g
- Registration Number
- NCT02763280
- Lead Sponsor
- Chonbuk National University Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- 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
- 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,.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Ginseng extract 1g Ginseng extract 1g Ginseng extract 1g Ginseng extract 3g Ginseng extract 3g Ginseng extract 3g
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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)
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 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 WOMAC index(Western ontario and mcmaster universities arthritis) Baseline and 12 week WOMAC index was measured in study baseline and visit 3(12 week)
Trial Locations
- Locations (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of