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
Overview
- Phase
- Phase 4
- Intervention
- γ-linoleic acid and placebo(Thioctic Acid)
- Conditions
- Diabetic Neuropathy
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 100
- Locations
- 11
- Primary Endpoint
- Changes of Visual Analog Scale(VAS)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Tae Sun Park
Obesity Research Center of Chonbuk National University
Chonbuk National University Hospital
Eligibility 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
Arms & Interventions
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.
Intervention: γ-linoleic acid and placebo(Thioctic Acid)
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.
Intervention: Thioctic Acid and placebo(γ-linoleic acid)
Outcomes
Primary Outcomes
Changes of Visual Analog Scale(VAS)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)