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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763280
• Other study ID #: RDA-BM-GE
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: February 1, 2018
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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,.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Dietary Supplement:
• Ginseng extract 1g
Ginseng extract 1g, parallel design
• Ginseng extract 3g
Ginseng extract 3g, parallel design
• Placebo
placebo, parallel design

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Serum Osteocalcin	Serum Osteocalcin was measured in study baseline and visit 3(12 week).	Baseline and 12 week
Primary	Changes in Urinary Deoxypyridinoline	Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).	Baseline and 12 week
Primary	Changes in DPD/OC ratio	DPD/OC ratio was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Secondary	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
Secondary	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
Secondary	Changes in Serum Ca, Phosphorus	Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Secondary	Changes in Serum BSALP(bone specific-alkaline phosphatase)	Serum BSALP was measured in study baseline and visit 3(12 week)	Baseline and 12 week
Secondary	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
Secondary	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