Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients who were between 20 years and 75 years at screening
Patients who were diagnosed with type 2 diabetes and whose HbA1c levels were less than 11% at screening
Patients with a score of 4 or more on the Visual Analogue Score(VAS)

One or more of the following items

If the physical examination score of the Michigan Neuropathy Screening Instrument Score (MNSI) is more than 2 points at the initial screening
type 2 diabetic patient who complained one or more of pain, burning sensation, numbness, and sensory loss and measured the current perception threshold (CPT) of the peroneal nerve at three frequencies (2000Hz, 250Hz, 5Hz) Anyone whose diabetes mellitus has been diagnosed as diabetic neuropathy
Patients who decided to voluntarily participate in clinical trials and agreed in writing

Exclusion Criteria:

Peripheral neuropathy caused by other causes other than diabetes
Those are suffering from other painful conditions that are so severe that diabetic neuropathy can not be assessed
If you have a progressive or degenerative neurological disorder
Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg
Patients who were positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) test
patients with liver dysfunction (ALT / AST> 3 times the upper limit of normal)
Patients with renal dysfunction (Serum creatine> 2.0 mg / dl)
Patients with thyroid dysfunction (Thyroid and anti-thyroid medications may be included in this study if they are maintained in normal state.)
Patients with amputation (including toes) or infections of the lower extremities

The following diseases are clinically significant patients

Unstable coronary artery disease or peripheral vascular disease
Liver, kidney, lung, hematologic disease
Cancer (within 5 years if possible)
Patients who have suicide attempts or suicidal tendencies and who have a psychiatric history within 6 months before starting the trial
Patients with substance abuse or chronic alcohol abuse within 2 years prior to taking the test
Patients who received intravenous steroid injection or topical anesthetic injection within 2 months before participating in the study
Patients who participated in other studies within 4 weeks before participating in the trial, or who are currently taking medication for other research
Screening After randomization for 2 weeks (pause period) before screening, antipsychotics, antipsychotics, sleep depressants, antidepressants, antiepileptics, muscle relaxants, analgesics (narcotic analgesics, NSAIDs, tramadol etc.) Patients who received capsaicin or who received percutaneous electrical nerve stimulation therapy (TENS) or acupuncture
Patients with a history of hypersensitivity or clinically significant hypersensitivity reactions to this drug substance and soybean oil, soy or peanut
Patients with clinically significant skin disease or severe skin irritability
Pregnant or lactating women
patients suffering from schizophrenia or those who are treated with chloropromazine, mesoridazine, thioridazine, fluphenazine, perphenazine, trifluoperazine, haloperidol (haloperidol), loxapine (loxapine) and other drugs known to cause epileptic seizures
In addition to the above items, patients who are deemed inappropriate by clinical trial researchers