NCT03914404

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chonbuk National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-26
• Primary completion: 2016-03-30
• Completion: 2018-07-25
• First posted: 2019-04-16
• Last updated: 2019-04-16

Locations

11 sites across 1 country: South Korea