A 12-week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Clinical Trial to Compare the Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Changes of Visual Analog Scale(VAS)
研究概览
简要总结
This study was a 12-week, multi-center, randomized, double-blind, double dummy, parallel clinical trial to compare the efficacy of γ-linolenic acid and Thioctic acid in patients with diabetic neuropathy.
详细描述
This study evaluated non-inferiority about the efficacy and safety of γ-linolenic acid (Evoprim soft capsule) through patients with diabetic neuropathy were compared γ-linolenic acid (Evoprim soft capsule) and Thioctic acid(LipoA HR Tab. 600mg) using double-blind, double dummy clinical trials. First outcome measures are Visual Analog Scale(VAS) and Total Symptom Score(TSS), secondary outcome measures are Michigan Neuropathy Screening Instrument(MNSI), Current perception Threshold(CPT), Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN) and EuroQol-5 Dimensions(EQ 5D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Test group
- γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time.
- Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.
干预措施: γ-linoleic acid and placebo(Thioctic Acid) (Drug)
Control Group
- Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time.
- γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.
干预措施: Thioctic Acid and placebo(γ-linoleic acid) (Drug)
结局指标
主要结局
Changes of Visual Analog Scale(VAS)
时间窗: 12 weeks
The Visual Analog Scale(VAS) score is 0 point for no symptom, 10 points for the most severe symptom, and the patient is asked to mark the degree of subjective pain symptoms as an integer.
Changes of Total Symptom Score(TSS)
时间窗: 12 weeks
Total Symptom Score(TSS) classifies diabetic neuropathy symptoms into four categories (pain, burning pain, paresthesia, numbness). The frequency (Occasional, Frequent, Continuous) and symptom intensity (Absent, Slight, Moderate, Severe) are calculated through each question and the score is obtained according to the visual analog scale. It is calculated from 0 point up to 14.64 points.
次要结局
- Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN)(12 weeks)
- Changes of Michigan Neuropathy Screening Instrument(MNSIQ)(12 weeks)
- Changes of Michigan Neuropathy Screening Instrument(MNSIE)(12 weeks)
- Changes of Current perception Threshold(CPT)(12 weeks)
- Changes of EuroQol-5 Dimensions(EQ 5D)(12 weeks)
研究者
Tae Sun Park
Obesity Research Center of Chonbuk National University
Chonbuk National University Hospital