CompletedPhase 4

Thymoquinone as an add-on Therapy for the Management of Patients With Diabetic Peripheral Neuropathy

Iraq50 participantsStarted 2024-07-01

Plain-language summary

The goal of this clinical trial is to evaluate the efficacy of thymoquinone as an adjuvant treatment with pregabalin in the management of diabetic peripheral neuropathy for both sexes older than 18 years. The main questions it aims to answer are: * Whether the use of thymoquinone could improve diabetic neuropathy and be confirmed by a nerve conduction study? * Could thymoquinone improve oxidative stress and inflammation by using these parameters (visfatin, calprotectin, malondialdehyde)? * Does thymoquinone improve neuropathic pain by using the VAS scale for pain?

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Both males or females of any race over 18 years of age.
✓. Patients with either type1 or type2 diabetes, who have been on a stable anti-diabetic medication regimen for at least 30 days before randomization.
✓. Duration of painful diabetic peripheral neuropathy was required to be more than 3 months.

Exclusion criteria

✕. History of smoking, alcohol consumption, and thyroid gland disorder.
✕. Patients with any kidney disorder or any conditions that could confound the assessment of pain due to diabetic peripheral neuropathy.

What they're measuring

peripheral nerve improvement through NCS

Timeframe: Evaluated at base time (before treatment) and two months after treatment

Trial details

NCT IDNCT07313111

SponsorHawler Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy (DPN) trials