OsteoporosisPhase 1NCT02931305
Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease
A Phase 1 study testing Epimedium Prenylflavonoids Extract in people with Osteoporosis and Cardiovascular Disease, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Cardiovascular Disease
- What is being tested?
- Epimedium Prenylflavonoids Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2016to Oct 2017
- Phase
- Phase 1
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men.
Who cannot join
- Hepatitis B patients
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Investigational Medicine Unit, National University Health System
Singapore, Singapore, 117599
Pei Ling Tan, 6601 2534, angelia_pei_ling_tan@nuhs.edu.sg
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Phase 1A Clinical Trial to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of a Standardized Epimedium Prenylflavonoids (EP) Extract (HSA Chinese Proprietary Medicine No: 123317) in Healthy Men.
The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.
Read the detailed description
Prenylflavonoids and its glycoside derivatives isolated from the Traditional Chinese Medicine (TCM), Epimedium, have potent estrogenic properties. The principal bioactive compounds in Epimedium are the prenylflavonoids, icaritin, and their glycosylated derivatives which can enhance osteoblastic differentiation and mineralization, inhibits bone resorption, and induces apoptosis of osteoclasts. Animal experiments indicate that icariin can prevent bone loss induced by ovariectomized (OVX) in rats, through its stimulatory effects on osteoblast growth and function, and inhibitory action on osteoclast cells.
Epimedium has also demonstrated significant cardiovascular benefits with positive actions on vascular reactivity, endothelial function and thrombosis in human subjects. Notably, icariin, demonstrated a significant nitric oxide (NO)-dependent vasorelaxation of precontracted coronary arterial rings with intact endothelium in a concentration-dependent manner, via the activation of endothelial nitric oxide synthase protein and NO-cyclic guanidine monophosphate (cGMP) pathway. Epimedium prenylflavonoids (EP) can prevent steroid-associated osteonecrosis in rabbit model and notably, reduce thrombosis incidence and shrink fat-cell-size significantly. This striking combination of properties highlights the immense potential in EP for osteoporosis and cardiovascular health.
- Conditions
- Osteoporosis, Cardiovascular Disease
- Being tested
- Epimedium Prenylflavonoids Extract, Placebo
- Keywords
- Epimedium prenylflavonoids, Osteoporosis, Cardiovascular diseases, Phase 1, safety, tolerability
- Medical subject headings
- Osteoporosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epimedium Prenylflavonoids ExtractDrug
Also called EP
Each Epimedium Prenylflavonoids Extract capsule contains 370 mg of EPIMEDIUM EXTRACT
PlaceboDrug
Use iron oxide (brown, black and yellow) to mimic Epimedium Prenylflavonoids Extract.
| Study group | Role | What they receive |
|---|---|---|
| Epimedium Prenylflavonoids Extract | Experimental | Single oral doses of EP (370 mg, 740 mg and 1110 mg) capsules would be orally administered. Receives: Drug: Epimedium Prenylflavonoids Extract |
| Placebo | Placebo comparator | Single oral doses of Placebo (370 mg, 740 mg and 1110 mg) capsules would be orally administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events/serious adverse events
Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs, hematology and clinical chemistry.
Measured: 8 to10 days
Secondary outcomes (11)
lcariin
Serum will be extracted from blood samples for measurement of levels of icariin using Liquid chromatography-mass spectrometry (LC/MS).
Measured: 3 months
Ex vivo osteoblast and osteoclast activities
Ex vivo assays using human serum to test the effects of EP in bone models of osteoblasts and osteoclasts
Measured: 6 to 9 months
Estrogenic biomarkers
The serum will be tested for cell based estrogen receptor bioassays, and its effects on Michigan Cancer Foundation-7 (MCF-7) cell proliferation will also be assessed.
Measured: 1 to 2 months
interleukin-6 (IL-6)
IL-6 assays for thrombosis
Measured: 1 month
high-sensitivity C-reactive protein (hs-CRP)
hs-CRP assays for thrombosis
Measured: 1 month
F2-isoprostanes
F2-isoprostanes assays for thrombosis
Measured: 1 month
multiple platelet aggregation
multiple platelet aggregation assays for thrombosis
Measured: 1 month
Icaritin (ICT)
Serum will be extracted from blood samples for measurement of levels of ICT using LC/MS.
Measured: 3 months
Demethylicaritin (DICT)
Serum will be extracted from blood samples for measurement of levels of DICT using LC/MS.
Measured: 3 months
icariside 1
Serum will be extracted from blood samples for measurement of levels of icariside 1 using LC/MS.
Measured: 3 months
icariside II
Serum will be extracted from blood samples for measurement of levels of icariside II using LC/MS.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obstetrics & Gynaecology, National University Hospital, Singapore
- Investigators
- Eu Leong Yong, MD & PhD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931305
- Sponsor's protocol ID
- EP2016
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Phase 1A Clinical Trial to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of a Standardized Epimedium Prenylflavonoids (EP) Extract (HSA Chinese Proprietary Medicine No: 123317) in Healthy Men.
- ClinicalTrials.gov ID
- NCT02931305
- Acronym / sponsor ID
- EP2016
- Conditions
- Osteoporosis, Cardiovascular Disease
- Keywords
- Epimedium prenylflavonoids, Osteoporosis, Cardiovascular diseases, Phase 1, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Oct 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.
The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.
Detailed description
Prenylflavonoids and its glycoside derivatives isolated from the Traditional Chinese Medicine (TCM), Epimedium, have potent estrogenic properties. The principal bioactive compounds in Epimedium are the prenylflavonoids, icaritin, and their glycosylated derivatives which can enhance osteoblastic differentiation and mineralization, inhibits bone resorption, and induces apoptosis of osteoclasts. Animal experiments indicate that icariin can prevent bone loss induced by ovariectomized (OVX) in rats, through its stimulatory effects on osteoblast growth and function, and inhibitory action on osteoclast cells.
Epimedium has also demonstrated significant cardiovascular benefits with positive actions on vascular reactivity, endothelial function and thrombosis in human subjects. Notably, icariin, demonstrated a significant nitric oxide (NO)-dependent vasorelaxation of precontracted coronary arterial rings with intact endothelium in a concentration-dependent manner, via the activation of endothelial nitric oxide synthase protein and NO-cyclic guanidine monophosphate (cGMP) pathway. Epimedium prenylflavonoids (EP) can prevent steroid-associated osteonecrosis in rabbit model and notably, reduce thrombosis incidence and shrink fat-cell-size significantly. This striking combination of properties highlights the immense potential in EP for osteoporosis and cardiovascular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epimedium Prenylflavonoids Extract | Experimental | Drug: Epimedium Prenylflavonoids ExtractSingle oral doses of EP (370 mg, 740 mg and 1110 mg) capsules would be orally administered. |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral doses of Placebo (370 mg, 740 mg and 1110 mg) capsules would be orally administered. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men.
Key exclusion criteria (1 listed)
- Hepatitis B patients
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 |
|---|---|---|
| Epimedium Prenylflavonoids ExtractAlso: EPEach Epimedium Prenylflavonoids Extract capsule contains 370 mg of EPIMEDIUM EXTRACT | Drug | Epimedium Prenylflavonoids Extract |
| PlaceboUse iron oxide (brown, black and yellow) to mimic Epimedium Prenylflavonoids Extract. | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events/serious adverse events
Time frame: 8 to10 days
Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs, hematology and clinical chemistry.
11 secondary outcomes
lcariin
Time frame: 3 months
Ex vivo osteoblast and osteoclast activities
Time frame: 6 to 9 months
Estrogenic biomarkers
Time frame: 1 to 2 months
interleukin-6 (IL-6)
Time frame: 1 month
high-sensitivity C-reactive protein (hs-CRP)
Time frame: 1 month
F2-isoprostanes
Time frame: 1 month
multiple platelet aggregation
Time frame: 1 month
Icaritin (ICT)
Time frame: 3 months
Demethylicaritin (DICT)
Time frame: 3 months
icariside 1
Time frame: 3 months
icariside II
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Eu Leong Yong, MD & PhD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epimedium Prenylflavonoids Extract in people with Osteoporosis and Cardiovascular Disease, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. 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 Singapore. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eu Leong Yong, MD & PhD (67724285, obgyel@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events/serious adverse events (time frame: 8 to10 days). 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 14 Oct 2016.