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

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

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?

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: Drug: stander treatment pregabalin; Dietary supplement: thymoquinone

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • IRAQ
    • Erbil, IRAQ, Iraq, 44001
      • Hawler medical university, Galyawa diabetic center and Neurophysiology department of hawler psychiatric hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (stander treatment only Pregabalin); Participants in this arm received 75 mg of pregabalin capsule orally for two months	Drug: stander treatment pregabalin; Participants received 75 mg of a pregabalin capsule for two months
Experimental: supplement (thymoquinone)+ standard treatment (pregabalin); participants in this arm received thymoquinone capsule 65 mg + pregabalin capsule 65 mg daily for two months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral nerve improvement through NCS	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.	Evaluated at base time (before treatment) and two months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxidative stress, and inflammatory parameter levels	Measurement of serum Visfatin, Calprotectin, Malondialdehyde, and HbA1c for all participants	Evaluated at baseline (before treatment) and two months after treatment

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: oxidative stress; diabetic neuropathy; thymoquinone; nerve conductive study
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; thymoquinone
• Other Study ID Numbers: HawlerMU-1; HawlerMU-TQPG_2025 (Other Identifier: Hawler Medical University, College of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time, individual participant data (IPD) will not be shared publicly. The data will be kept confidential to ensure participant privacy and comply with ethical and regulatory requirements, including those related to informed consent and data protection. Access to the data may be considered for future collaborations under strict ethical guidelines and approval from the relevant oversight bodies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No