Status:

UNKNOWN

Effect of High-Dose NAC on Patients With DPN

Lead Sponsor:

Ain Shams University

Conditions:

Diabetic Neuropathies

Eligibility:

All Genders

18-50 years

Phase:

PHASE4

Brief Summary

The aim of the current study is to evaluate the efficacy and safety of high dose oral NAC (2400 mg/day divided into two doses) as an adjunct therapy on oxidative stress, inflammatory markers and clini...

Detailed Description

Patient written informed consent will be taken prior to study conductance * Lab assessment will be done at baseline and at the end of the study by withdrawing 7 ml of whole blood for assessment of fo...

Eligibility Criteria

Inclusion

  • Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
  • Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).

Exclusion

  • Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
  • Pregnancy or lactation or expecting to get pregnant during the study.
  • Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
  • Cancer patients.
  • Anyone having hypersensitivity to N-acetylcysteine.
  • Anyone already taking N-acetylcysteine.

Key Trial Info

Start Date :

December 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2022

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04766450

Start Date

December 1 2021

End Date

December 1 2022

Last Update

August 8 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Demerdash Hospital

Cairo, Egypt, 02