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Completed

NCT Number: NCT07313111

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

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?

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Key information

Conditions

Diabetic Peripheral Neuropathy (DPN) Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hawler medical university, Galyawa diabetic center and Neurophysiology department of hawler psychiatric hospital

Erbil, IRAQ, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stander treatment pregabalin

Drug

Participants received 75 mg of a pregabalin capsule for two months

thymoquinone

Dietary Supplement

participants recieved 65 mg of thymoquinone capsule daily for two months

Primary outcomes

  1. peripheral nerve improvement through NCS

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

    NCS assessment of both upper and lower limbs to detect diabetic neuropathy, including measurement tools: latency, amplitude, and conduction velocity for motor and sensory nerves.

Secondary outcomes

  1. oxidative stress, and inflammatory parameter levels

    Time frame: Evaluated at baseline (before treatment) and two months after treatment

    Measurement of serum Visfatin, Calprotectin, Malondialdehyde, and HbA1c for all participants

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Acronym: TQDPN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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