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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
* 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.
* 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.
Sejong hospital
Bucheon-si, Gyeonggi-do, South Korea
Obesity Research Center of Chonbuk National University
Jeonju, Jeollabuk-do, South Korea
Dongguk university gyeongju hospital
Gyeongju, North Gyeongsang-do, South Korea
Changes of Visual Analog Scale(VAS)
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.
Time frame: 12 weeks
Changes of Total Symptom Score(TSS)
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.
Time frame: 12 weeks
Changes of Michigan Neuropathy Screening Instrument(MNSIQ)
A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIQ was designed to screen for diabetic neuropathy through questionnaires on 15 questions that are related to neuropathic symptoms (pain, temperature, and sensation). Two of 15 (number 4 and 10) are vascular symptoms and are excluded from the total score regardless of the results. If you answered 'No' to questions 7 and 13, you will get 1 point. In the end, scores ranging from 0 to 13 indicate that the higher the score, the more severe the neuropathic symptoms.
Time frame: 12 weeks
Changes of Michigan Neuropathy Screening Instrument(MNSIE)
A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIE evaluates foot shape, foot ulceration, ankle reflex, sense of vibration of big toe, monofilament right and left. The score ranges from point 0 to 10, and when the score is above 2, it is diagnosed as neuropathy.
Time frame: 12 weeks
Changes of Current perception Threshold(CPT)
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Soon chun hyang university hospital cheonan
Cheonan, South Chungcheong Province, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Pusan National University Hospital
Pusan, South Korea
Inje university sanggye paik hospital
Seoul, South Korea
Yonsei univesity severance hospital
Seoul, South Korea
The catholic university of korea seoul st. mary's hospital
Seoul, South Korea
...and 1 more locations
Sensory nerve conduction threshold (SNCT) is a unique method for evaluating all three sensory neurons (small unmyelinated fibers, small myelinated fibers, and large myelinated fibers) that make up more than 90% of sensory nerves. It seems to be possible to objectively evaluate sensory nerve of small fiber which recovered early in diabetic neuropathy(Using neurometer).
Time frame: 12 weeks
Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN)
Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN) displays the pain area on the human figure, the number of pain sites, treatment of pain, and pain medication. Pain severity refers to the pain sensation- identification aspect (pain threshold). The worst pain, the least pain, the pain average, and the pain now for the last 24 hours are displayed on the 10-point scale (0 points: none, \~ 10 Point: too big to imagine). Pain interference is the emotional-synchronous aspect of pain (pain tolerance). It classifies general activity, mood, walking, working, relationship, sleep and enjoyment of life, and use the 10-point scale (0 points: none to 10 points: completely disturbed).
Time frame: 12 weeks
Changes of EuroQol-5 Dimensions(EQ 5D)
EQ-5D index = 1 - (0.050 + 0.096 M2 + 0.418 x M3 + 0.046 x SC2 + 0.13 x SC3 + 0.051 x UA2 + 0.028 x UA3 + 0.037 x PD2 + 0.151 x PD3 + 0.043 x AD2 + 0.158 x AD3 + 0.050 × N3) - 1 if the variable is applicable, 0 if not (M: mobility, SC: self-care, UA: usual activity,, PD: pain / discomfort, AD: anxiety / depression) \* Variable definition * M2: 1 if mobility is 'level 2', 0 if not * M3: 1 if mobility is 'level 3', 0 if not * SC2: 1 if self-care is 'level 2', 0 if not * SC3: 1 if self-care is 'level 3', 0 if not * UA2: 1 if usual activity is 'level 2', 0 if not * UA3: 1 if usual activity is 'level 3', 0 if not * PD2: 1 if pain / discomfort is 'level 2', 0 if not * PD3: 1 if pain / discomfort is 'level 3', 0 if not * AD2: 1 if anxiety / depression is 'level 2', 0 if not * AD3: 1 if anxiety / depression is 'level 3', 0 if not * N3: 1 if there is at least one level 3, others are 0
Time frame: 12 weeks