NCT07313111

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

Efficacy of Thymoquinone as an Adjuvant Treatment With Pregabalin for the Treatment of Neuropathy in Diabetic Patients: A Randomized Clinical Trial of 65 mg of Thymoquinone and 75 mg Pregabalin Daily for Two Months

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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?

Detailed description

Study Design and Methodology This is a randomized, clinical trial designed to evaluate the neuroprotective effects of thymoquinone in diabetic patients with neuropathy. Study Sites Primary Location: Galyawa diabetic center and Neurophysiology Department of Hawler Psychiatric Hospital, affiliated with Hawler Medical University. Multicenter expansion was considered, but all participants were recruited at the primary site. Study Population Enrollment (Actual): 50 participants with diabetic neuropathy Groups: Group 1 (n=25): DPN patients on Pregabalin 75 mg daily for 2 months. Group 2 (n=25): DPN patients on Pregabalin 75 mg + Thymoquinone 65 mg daily for 2 months. Follow-up Period Duration: 2 months from initiation of treatment. Assessment intervals: Baseline (pre-treatment) and 2 months (post-treatment). Primary outcome: A Nerve conductive study was done, and blood samples for (visfatin, calprotectin, malondialdehyde, and HbA1c) measurement were drawn before starting treatment. Secondary or Endpoints: the same investigations were done after two months of treatment Adverse Events: Monitored continuously throughout the 2-month treatment and follow-up, including risks of epigastric pain, dizziness, and headache. Statistical Analysis Plan Sample Size: Originally planned for 80 patients, but 50 were enrolled (25 per group). Comparative Analysis: Paired t-tests, Wilcoxon signed-rank tests (for non-parametric data), ANOVA for repeated measures where appropriate. Ethical Considerations Approved by the Hawler Medical University Ethics Committee. Written informed consent was obtained from all participants. Potential Impact: If thymoquinone proves effective, this study could support the use of thymoquinone as a neuroprotective strategy in diabetic neuropathic patients, improving NCS outcomes and quality of life.

Conditions

• Diabetic Peripheral Neuropathy (DPN)

Interventions

Type	Name	Description
DRUG	stander treatment pregabalin	Participants received 75 mg of a pregabalin capsule for two months
DIETARY_SUPPLEMENT	thymoquinone	participants recieved 65 mg of thymoquinone capsule daily for two months

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Iraq