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

Primary Purpose

Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ginseng extract 1g
Ginseng extract 3g
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts 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,.

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ginseng extract 1g

Ginseng extract 3g

Placebo

Arm Description

Ginseng extract 1g

Ginseng extract 3g

Placebo

Outcomes

Primary Outcome Measures

Changes in Serum Osteocalcin
Serum Osteocalcin was measured in study baseline and visit 3(12 week).
Changes in Urinary Deoxypyridinoline
Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).
Changes in DPD/OC ratio
DPD/OC ratio was measured in study baseline and visit 3(12 week)

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2016
Last Updated
February 1, 2018
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02763280
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginseng extract 1g
Arm Type
Experimental
Arm Description
Ginseng extract 1g
Arm Title
Ginseng extract 3g
Arm Type
Experimental
Arm Description
Ginseng extract 3g
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginseng extract 1g
Intervention Description
Ginseng extract 1g, parallel design
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginseng extract 3g
Intervention Description
Ginseng extract 3g, parallel design
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo, parallel design
Primary Outcome Measure Information:
Title
Changes in Serum Osteocalcin
Description
Serum Osteocalcin was measured in study baseline and visit 3(12 week).
Time Frame
Baseline and 12 week
Title
Changes in Urinary Deoxypyridinoline
Description
Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).
Time Frame
Baseline and 12 week
Title
Changes in DPD/OC ratio
Description
DPD/OC ratio was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Secondary Outcome Measure Information:
Title
Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)
Description
Serum CTX was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Title
Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)
Description
Serum NTX was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Title
Changes in Serum Ca, Phosphorus
Description
Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Title
Changes in Serum BSALP(bone specific-alkaline phosphatase)
Description
Serum BSALP was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Title
Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)
Description
Serum P1NP was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week
Title
Changes in WOMAC index(Western ontario and mcmaster universities arthritis)
Description
WOMAC index was measured in study baseline and visit 3(12 week)
Time Frame
Baseline and 12 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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