YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
NCT ID: NCT01836172
Last Updated: 2016-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
136 participants
INTERVENTIONAL
2013-04-30
2017-01-31
Brief Summary
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Detailed Description
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The secondary purposes of this study are divided into three as follows;
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference of FMD, compared to placebo group after treatment of 8 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on insulin resistance in diabetes mellitus indicated as mean change difference of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), compared to placebo group after treatment of 4, 8 and 12 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on mean change difference of blood pressure in diabetes mellitus, compared to placebo group after treatment of 4, 8 and 12 weeks.
The exploratory purposes of this study are divided into two as follows;
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on blood glucose level in diabetes mellitus indicated as mean change difference of HbA1c, compared to placebo group after treatment of 12 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on vascular stiffness in diabetes mellitus indicated as mean change difference of blood lipids (LDL, HDL and TG), compared to placebo group after treatment of 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo t.i.d.
Placebo t.i.d.
YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
YJP-14 25 mg t.i.d.
YJP-14 25 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.
YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
YJP-14 50 mg t.i.d.
YJP-14 50 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.
YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
YJP-14 100 mg t.i.d.
YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. YJP-14 100 mg t.i.d.
YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Interventions
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YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Han Wha Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Byung-Hee Oh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Internal medicine, Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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References
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Lee JO, Oak MH, Jung SH, Park DH, Auger C, Kim KR, Lee SW, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems causes NO-mediated endothelium-dependent relaxations in rat aortic rings and prevents angiotensin II-induced hypertension and endothelial dysfunction in rats. Naunyn Schmiedebergs Arch Pharmacol. 2011 Jun;383(6):635-45. doi: 10.1007/s00210-011-0643-9. Epub 2011 May 2.
Lee JO, Auger C, Park DH, Kang M, Oak MH, Kim KR, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems, YJP-14, improves endothelial dysfunction, metabolic parameters and physical performance in diabetic db/db mice. PLoS One. 2013 Jun 3;8(6):e65227. doi: 10.1371/journal.pone.0065227. Print 2013.
Other Identifiers
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HW2012-YJP002
Identifier Type: -
Identifier Source: org_study_id
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