NCT01836172

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the treatment of endothelial dysfunction in patients with diabetes mellitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

3.7 years

First QC Date

April 17, 2013

Last Update Submit

August 16, 2016

Conditions

Diabetic Complication

Keywords

The treatment of diabetic complication

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilation (FMD)

    12 weeks

Secondary Outcomes (3)

  • Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure

    8 weeks

  • Homeostasis model assessment-insulin resistance (HOMA-IR)

    4, 8, 12 weeks

  • Systolic and Diastolic Blood Pressure

    4, 8, 12 weeks

Other Outcomes (2)

  • HbA1c Serum lipids (LDL, HDL and TG)

    12 weeks

  • Serum Lipids (LDL, HDL and TG)

    12 weeks

Study Arms (4)

Placebo t.i.d.

PLACEBO COMPARATOR

Placebo t.i.d.

Drug: YJP-14

YJP-14 25 mg t.i.d.

PLACEBO COMPARATOR

YJP-14 25 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.

Drug: YJP-14

YJP-14 50 mg t.i.d.

PLACEBO COMPARATOR

YJP-14 50 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.

Drug: YJP-14

YJP-14 100 mg t.i.d.

PLACEBO COMPARATOR

YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. YJP-14 100 mg t.i.d.

Drug: YJP-14

Interventions

YJP-14DRUG

An 50% ethanolic extract of Lindera obtusiloba stems

Also known as: An 50% ethanolic extract of Lindera obtusiloba stems
Placebo t.i.d.YJP-14 100 mg t.i.d.YJP-14 25 mg t.i.d.YJP-14 50 mg t.i.d.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent), Endothelial dysfunction: FMD below 6.7%, LDL cholesterol level less than 140 mg/dl, Patients agreed to Informed Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal medicine, Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 21533989BACKGROUND

  • 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.

    PMID: 23755196BACKGROUND

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System Diseases

Study Officials

  • Byung-Hee Oh, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

KR(1)