YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus

Multicenter, Randomized, Double Blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Safety and Efficacy of YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836172

Enrollment

136

Registered

2013-04-19

Start date

2013-04-30

Completion date

2017-01-31

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Complication

Keywords

The treatment of diabetic complication

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.

Detailed description

The primary purpose of this study is to demonstrate superior 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 flow-mediated dilation (FMD), compared to placebo group after treatment of 12 weeks. 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.

Interventions

DRUGYJP-14

An 50% ethanolic extract of Lindera obtusiloba stems

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

(Key

Design outcomes

Primary

Measure	Time frame
Flow-mediated dilation (FMD)	12 weeks

Secondary

Measure	Time frame
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

Measure	Time frame
HbA1c Serum lipids (LDL, HDL and TG)	12 weeks
Serum Lipids (LDL, HDL and TG)	12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026