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Trial record 14 of 55 for:    linolenic acid

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
Sponsor:
Information provided by (Responsible Party):
Tae Sun Park, Chonbuk National University Hospital

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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: γ-linoleic acid and placebo(Thioctic Acid)
  • 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.

Experimental: 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.
Drug: Thioctic Acid and placebo(γ-linoleic acid)
  • 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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.


  2. 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.


  3. 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).

  4. 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).


  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Sejong hospital
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
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
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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

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Responsible Party: Tae Sun Park, Obesity Research Center of Chonbuk National University, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03914404     History of Changes
Other Study ID Numbers: DLB-DN-EVOP
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thioctic Acid
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Evening primrose oil
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Dermatologic Agents