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

Chonbuk National University

Status: Completed

Conditions: Osteopenia

Treatments: Dietary Supplement: Ginseng extract 1g; Dietary Supplement: Placebo; Dietary Supplement: Ginseng extract 3g

Study type: Interventional

Funder types: Other

Identifiers

NCT02763280

RDA-BM-GE

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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,.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups, including a placebo group

Ginseng extract 1g

Experimental group

Description:

Ginseng extract 1g

Treatment:

Dietary Supplement: Ginseng extract 1g

Ginseng extract 3g

Experimental group

Description:

Ginseng extract 3g

Treatment:

Dietary Supplement: Ginseng extract 3g

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo