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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT02931305 |
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Date of registration:
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06/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease
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Scientific title:
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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. |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02931305 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Eu Leong Yong, MD & PhD |
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Address:
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Telephone:
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67724285 |
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Email:
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obgyel@nus.edu.sg |
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Affiliation:
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Name:
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Pei Ling Tan |
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Address:
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Telephone:
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6601 2534 |
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Email:
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angelia_pei_ling_tan@nuhs.edu.sg |
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Affiliation:
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Name:
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Eu Leong Yong, MD & PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Hospital, Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy men.
Exclusion Criteria:
- Hepatitis B patients
Age minimum:
21 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Cardiovascular Disease
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Osteoporosis
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Intervention(s)
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Drug: Epimedium Prenylflavonoids Extract
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Drug: Placebo
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Primary Outcome(s)
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Incidence and severity of adverse events/serious adverse events
[Time Frame: 8 to10 days]
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Secondary Outcome(s)
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Ex vivo osteoblast and osteoclast activities
[Time Frame: 6 to 9 months]
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icariside II
[Time Frame: 3 months]
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Demethylicaritin (DICT)
[Time Frame: 3 months]
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multiple platelet aggregation
[Time Frame: 1 month]
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interleukin-6 (IL-6)
[Time Frame: 1 month]
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Icaritin (ICT)
[Time Frame: 3 months]
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Estrogenic biomarkers
[Time Frame: 1 to 2 months]
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F2-isoprostanes
[Time Frame: 1 month]
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icariside 1
[Time Frame: 3 months]
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lcariin
[Time Frame: 3 months]
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high-sensitivity C-reactive protein (hs-CRP)
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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