Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT03914404|
Recruitment Status : Completed
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Drug: γ-linoleic acid and placebo(Thioctic Acid) Drug: Thioctic Acid and placebo(γ-linoleic acid)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||January 26, 2016|
|Actual Primary Completion Date :||March 30, 2016|
|Actual Study Completion Date :||July 25, 2018|
Experimental: Test group
Drug: γ-linoleic acid and placebo(Thioctic Acid)
Experimental: Control Group
Drug: Thioctic Acid and placebo(γ-linoleic acid)
- 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.
- Changes of Michigan Neuropathy Screening Instrument(MNSIQ) [ Time Frame: 12 weeks ]
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.
- Changes of Michigan Neuropathy Screening Instrument(MNSIE) [ Time Frame: 12 weeks ]
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.
- Changes of Current perception Threshold(CPT) [ Time Frame: 12 weeks ]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).
- Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN) [ Time Frame: 12 weeks ]
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).
- Changes of EuroQol-5 Dimensions(EQ 5D) [ Time Frame: 12 weeks ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914404
|Korea, Republic of|
|Bucheon, Gyeonggi, Korea, Republic of, 14754|
|Obesity Research Center of Chonbuk National University|
|Jeonju, Jeollabuk-do, Korea, Republic of, 54907|
|Dongguk university gyeongju hospital|
|Gyeongju, North Gyeongsang-do, Korea, Republic of, 38067|
|Soon chun hyang university hospital cheonan|
|Cheonan, South Chungcheong Province, Korea, Republic of, 31151|
|Daegu Catholic University Medical Center|
|Daegu, Korea, Republic of, 42472|
|Gachon University Gil Medical Center|
|Incheon, Korea, Republic of, 2156|
|Pusan National University Hospital|
|Pusan, Korea, Republic of, 49241|
|Inje university sanggye paik hospital|
|Seoul, Korea, Republic of, 01757|
|Yonsei univesity severance hospital|
|Seoul, Korea, Republic of, 03722|
|The catholic university of korea seoul st. mary's hospital|
|Seoul, Korea, Republic of, 06591|
|The catholic university of korea Yeouido st. mary's hospital|
|Seoul, Korea, Republic of, 07345|
|Principal Investigator:||Bong-Yeon Cha, MD,PhD||The Catholic University of Korea|
|Principal Investigator:||Jong hwa Kim, MD||Sejong hospital|
|Principal Investigator:||Lee-byeong Park, MD,PhD||Gachon University Gil Medical Center|
|Principal Investigator:||Hyuk Sang Kwon, MD,PhD||The catholic university of korea Yeouido st. mary's hospital|
|Principal Investigator:||In Joo Kim, MD,PhD||Pusan National University Hospital|
|Principal Investigator:||Ji hyun Lee, MD,PhD||Daegu Catholic University Medical Center|
|Principal Investigator:||sung soo Moon, MD,PhD||DongGuk University|
|Principal Investigator:||Sung wan Chun, MD,PhD||Soon Chun Hyang University|
|Principal Investigator:||Byung-Wan Lee, MD,PhD||Yonsei univesity severance hospital|
|Principal Investigator:||Jong chul Won, MD,PhD||Inje University|
|Principal Investigator:||Tae-Sun Park, MD,PhD||Chonbuk National University Hospital|