Clinical trial NCT02763280: Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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,.

Primary outcomes:
measure: Changes in Serum Osteocalcin
timeFrame: Baseline and 12 week
measure: Changes in Urinary Deoxypyridinoline
timeFrame: Baseline and 12 week
measure: Changes in DPD/OC ratio
timeFrame: Baseline and 12 week
Secondary outcomes:
measure: Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)
timeFrame: Baseline and 12 week
measure: Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)
timeFrame: Baseline and 12 week
measure: Changes in Serum Ca, Phosphorus
timeFrame: Baseline and 12 week
measure: Changes in Serum BSALP(bone specific-alkaline phosphatase)
timeFrame: Baseline and 12 week
measure: Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)
timeFrame: Baseline and 12 week
measure: Changes in WOMAC index(Western ontario and mcmaster universities arthritis)
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: