OsteopeniaNCT02763280
Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women
A study testing Ginseng extract 1g and Ginseng extract 3g in people with Osteopenia, run by Chonbuk National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Ginseng extract 1g and Ginseng extract 3g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
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
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.
Read the 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).
- Conditions
- Osteopenia
- Being tested
- Ginseng extract 1g, Ginseng extract 3g, Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginseng extract 1gDietary supplement
Ginseng extract 1g, parallel design
Ginseng extract 3gDietary supplement
Ginseng extract 3g, parallel design
PlaceboDietary supplement
placebo, parallel design
| Study group | Role | What they receive |
|---|---|---|
| Ginseng extract 1g | Experimental | Ginseng extract 1g Receives: Dietary Supplement: Ginseng extract 1g |
| Ginseng extract 3g | Experimental | Ginseng extract 3g Receives: Dietary Supplement: Ginseng extract 3g |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Serum Osteocalcin
Serum Osteocalcin was measured in study baseline and visit 3(12 week).
Measured: Baseline and 12 week
Changes in Urinary Deoxypyridinoline
Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).
Measured: Baseline and 12 week
Changes in DPD/OC ratio
DPD/OC ratio was measured in study baseline and visit 3(12 week)
Measured: Baseline and 12 week
Secondary outcomes (6)
Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)
Serum CTX was measured in study baseline and visit 3(12 week)
Measured: 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)
Measured: Baseline and 12 week
Changes in Serum Ca, Phosphorus
Serum Ca, Phosphorus was measured in study baseline and visit 3(12 week)
Measured: Baseline and 12 week
Changes in Serum BSALP(bone specific-alkaline phosphatase)
Serum BSALP was measured in study baseline and visit 3(12 week)
Measured: 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)
Measured: 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)
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763280
- Sponsor's protocol ID
- RDA-BM-GE
- Status last verified
- Feb 2018
- First submitted
- 9 Mar 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02763280
- Acronym / sponsor ID
- RDA-BM-GE
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ginseng extract 1g | Experimental | Dietary Supplement: Ginseng extract 1gGinseng extract 1g |
| Ginseng extract 3g | Experimental | Dietary Supplement: Ginseng extract 3gGinseng extract 3g |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginseng extract 1gGinseng extract 1g, parallel design | Dietary supplement | Ginseng extract 1g |
| Ginseng extract 3gGinseng extract 3g, parallel design | Dietary supplement | Ginseng extract 3g |
| Placeboplacebo, parallel design | Dietary supplement | Placebo |
Primary outcome
Changes in Serum Osteocalcin
Time frame: Baseline and 12 week
Serum Osteocalcin was measured in study baseline and visit 3(12 week).
Changes in Urinary Deoxypyridinoline
Time frame: Baseline and 12 week
Urinary Deoxypyridinoline was measured in study baseline and visit 3(12 week).
Changes in DPD/OC ratio
Time frame: Baseline and 12 week
DPD/OC ratio was measured in study baseline and visit 3(12 week)
6 secondary outcomes
Changes in Serum CTX(Cross-linked C-telopeptide of type-1 collagen)
Time frame: Baseline and 12 week
Changes in Serum NTX(Cross-linked N-telopeptide of type-1 collagen)
Time frame: Baseline and 12 week
Changes in Serum Ca, Phosphorus
Time frame: Baseline and 12 week
Changes in Serum BSALP(bone specific-alkaline phosphatase)
Time frame: Baseline and 12 week
Changes in Serum P1NP(procollagen type 1 N-terminal propeptide)
Time frame: Baseline and 12 week
Changes in WOMAC index(Western ontario and mcmaster universities arthritis)
Time frame: Baseline and 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginseng extract 1g and Ginseng extract 3g in people with Osteopenia, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Serum Osteocalcin (time frame: Baseline and 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.