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Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt

NCT05813496 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2025-03-25

No results posted yet for this study

Summary

The purpose of the study is to find out whether ALA is effective and safe for treating Egyptian diabetic patients with symptomatic polyneuropathy. The ADA stated that despite the exploration of several pharmacological therapies for DPN management, substantial evidence on medicines that modify the natural history of DPN is still absent. This is a multicenter, interventional, two-arm, parallel-group, randomized, double-blinded, placebo-controlled, phase IV trial. Patients will be administered either one tablet of placebo or one tablet containing 600 mg of ALA twice a day for 24 weeks, depending on the randomization process.

Conditions

  • Polyneuropathy, Diabetic

Interventions

DRUG

Alpha-Lipoic Acid (ALA)

Oral tablet

DRUG

Placebo

Microcrystalline cellulose (Ph 101) 427.5 mg, Magnesium stearate 71.25 mg, Sodium laurayl sulphate 6 mg, Croscarmellose sodium 11.25 mg, Silica, colloid anhydrous 11.25 mg, and Purified talc 30 mg.

Sponsors & Collaborators

  • MARC-CRO

    collaborator UNKNOWN

  • Eva Pharma

    lead INDUSTRY

Principal Investigators

  • Samir H Assaad Khali, PhD · Alexandria University Hospital / Internal Medicine

  • Mohamed R Halawa, PhD · Ain-Shams University Hospital / Internal Medicine

  • Nabil AF El Kafrawy, PhD · Menoufia University Hospital / Internal Medicine

  • Hanan M El Sotouhy Gawish, PhD · Mansoura University Hospital / Internal Medicine

  • Khaled ES El Hadidy, PhD · Beni Suef University Hospital / Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2024-08-03
Completion
2024-12-11

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813496 on ClinicalTrials.gov