NCT02763280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

March 9, 2016

Last Update Submit

February 1, 2018

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

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

    Baseline and 12 week

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

    Baseline and 12 week

  • Changes in Serum Ca, Phosphorus

    Baseline and 12 week

  • Changes in Serum BSALP(bone specific-alkaline phosphatase)

    Baseline and 12 week

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

    Baseline and 12 week

  • +1 more secondary outcomes

Study Arms (3)

Ginseng extract 1g

EXPERIMENTAL

Ginseng extract 1g

Dietary Supplement: Ginseng extract 1g

Ginseng extract 3g

EXPERIMENTAL

Ginseng extract 3g

Dietary Supplement: Ginseng extract 3g

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Ginseng extract 1gDIETARY_SUPPLEMENT

Ginseng extract 1g, parallel design

Ginseng extract 1g
Ginseng extract 3gDIETARY_SUPPLEMENT

Ginseng extract 3g, parallel design

Ginseng extract 3g
PlaceboDIETARY_SUPPLEMENT

placebo, parallel design

Placebo

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

March 9, 2016

First Posted

May 5, 2016

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

September 1, 2016

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

KR(1)