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

Chonbuk National University Hospital90 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Osteopenia

Interventions

Ginseng extract 1gDIETARY_SUPPLEMENT

Ginseng extract 1g, parallel design

Ginseng extract 3gDIETARY_SUPPLEMENT

Ginseng extract 3g, parallel design

PlaceboDIETARY_SUPPLEMENT

placebo, parallel design

Eligibility

Sex: FEMALEMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,.

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea