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

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.

Conditions

• Diabetic Neuropathy

Interventions

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.

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.

Sponsors & Collaborators

• Chonbuk National University Hospital

  lead OTHER

Principal Investigators

• Bong-Yeon Cha, MD,PhD · The Catholic University of Korea

• Jong hwa Kim, MD · Sejong General Hospital

• Lee-byeong Park, MD,PhD · Gachon University Gil Medical Center

• Hyuk Sang Kwon, MD,PhD · The catholic university of korea Yeouido st. mary's hospital

• In Joo Kim, MD,PhD · Pusan National University Hospital

• Ji hyun Lee, MD,PhD · Daegu Catholic University Medical Center

• sung soo Moon, MD,PhD · DongGuk University

• Sung wan Chun, MD,PhD · Soon Chun Hyang University

• Byung-Wan Lee, MD,PhD · Yonsei univesity severance hospital

• Jong chul Won, MD,PhD · Inje University

• Tae-Sun Park, MD,PhD · Chonbuk National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-26

Primary Completion

2016-03-30

Completion

2018-07-25

Countries

• South Korea

Study Locations