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

Diabetic Neuropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03914404
Study type Interventional
Source Chonbuk National University Hospital
Contact
Status Completed
Phase Phase 4
Start date January 26, 2016
Completion date July 25, 2018
View Details
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