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

Hawler Medical University

Status and phase: Completed; Phase 4

Conditions: Diabetic Peripheral Neuropathy (DPN)

Treatments: Drug: stander treatment pregabalin; Dietary Supplement: thymoquinone

Study type: Interventional

Funder types: Other

Identifiers

NCT07313111

HawlerMU-TQPG_2025 (Other Identifier)

HawlerMU-1

Details and patient eligibility

About

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?

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Control group (stander treatment only Pregabalin)

Active Comparator group

Description:

Participants in this arm received 75 mg of pregabalin capsule orally for two months

Treatment:

Drug: stander treatment pregabalin

supplement (thymoquinone)+ standard treatment (pregabalin)

Experimental group

Description:

participants in this arm received thymoquinone capsule 65 mg + pregabalin capsule 65 mg daily for two months

Treatment:

Dietary Supplement: thymoquinone

Drug: stander treatment pregabalin