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Completed

NCT Number: NCT02763280

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,.

Treatment and study plan

Ginseng extract 1g

Dietary Supplement

Ginseng extract 1g, parallel design

Ginseng extract 3g

Dietary Supplement

Ginseng extract 3g, parallel design

Placebo

Dietary Supplement

placebo, parallel design

Primary outcomes

  1. Changes in Serum Osteocalcin

    Time frame: Baseline and 12 week

    Serum Osteocalcin was measured in study baseline and visit 3(12 week).

  2. Changes in Urinary Deoxypyridinoline

    Time frame: Baseline and 12 week

    Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).

  3. 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

  1. Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)

    Time frame: Baseline and 12 week

    Serum CTX was measured in study baseline and visit 3(12 week)

  2. Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)

    Time frame: Baseline and 12 week

    Serum NTX was measured in study baseline and visit 3(12 week)

  3. Changes in Serum Ca, Phosphorus

    Time frame: Baseline and 12 week

    Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week)

  4. Changes in Serum BSALP(bone specific-alkaline phosphatase)

    Time frame: Baseline and 12 week

    Serum BSALP was measured in study baseline and visit 3(12 week)

  5. Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)

    Time frame: Baseline and 12 week

    Serum P1NP was measured in study baseline and visit 3(12 week)

  6. Changes in WOMAC index(Western ontario and mcmaster universities arthritis)

    Time frame: Baseline and 12 week

    WOMAC index was measured in study baseline and visit 3(12 week)

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 5, 2016
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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