Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy

NCT ID: NCT03914404

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-26
• Study Completion Date: 2018-07-25

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).

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

γ-linoleic acid and placebo(Thioctic Acid)

Intervention Type: DRUG

• 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.

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.

Group Type: EXPERIMENTAL

Thioctic Acid and placebo(γ-linoleic acid)

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae Sun Park

Obesity Research Center of Chonbuk National University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bong-Yeon Cha, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Jong hwa Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Sejong General Hospital

Lee-byeong Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Hyuk Sang Kwon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The catholic university of korea Yeouido st. mary's hospital

In Joo Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Ji hyun Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

sung soo Moon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Sung wan Chun, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University

Byung-Wan Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei univesity severance hospital

Jong chul Won, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Tae-Sun Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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

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

The catholic university of korea Yeouido st. mary's hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DLB-DN-EVOP

Identifier Type: -

Identifier Source: org_study_id