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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Dietary supplement: Ginseng extract 1g; Dietary supplement: Ginseng extract 3g; Dietary supplement: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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,.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; placebo, parallel design
Experimental: Ginseng extract 1g	Dietary supplement: Ginseng extract 1g; Ginseng extract 1g, parallel design
Experimental: Ginseng extract 3g	Dietary supplement: Ginseng extract 3g; Ginseng extract 3g, parallel design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Serum Osteocalcin	Serum Osteocalcin was measured in study baseline and visit 3(12 week).	Baseline and 12 week
Changes in Urinary Deoxypyridinoline	Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).	Baseline and 12 week
Changes in DPD/OC ratio	DPD/OC ratio was measured in study baseline and visit 3(12 week)	Baseline and 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)	Serum CTX was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)	Serum NTX was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Changes in Serum Ca, Phosphorus	Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Changes in Serum BSALP(bone specific-alkaline phosphatase)	Serum BSALP was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)	Serum P1NP was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Changes in WOMAC index(Western ontario and mcmaster universities arthritis)	WOMAC index was measured in study baseline and visit 3(12 week)	Baseline and 12 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: RDA-BM-GE