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

NCT07313111 | Completed Phase 4

• 2 other identifiers: HawlerMU-1HawlerMU-TQPG_2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

diabetic neuropathy; thymoquinone; nerve conductive study; oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• oxidative stress, and inflammatory parameter levels

  Evaluated at baseline (before treatment) and two months after treatment

Study Arms (2)

Control group (stander treatment only Pregabalin)

ACTIVE COMPARATOR

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

Drug: stander treatment pregabalin

supplement (thymoquinone)+ standard treatment (pregabalin)

EXPERIMENTAL

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

Drug: stander treatment pregabalin; Dietary Supplement: thymoquinone

Interventions

thymoquinone DIETARY_SUPPLEMENT

participants recieved 65 mg of thymoquinone capsule daily for two months

supplement (thymoquinone)+ standard treatment (pregabalin)

stander treatment pregabalin DRUG

Participants received 75 mg of a pregabalin capsule for two months

Control group (stander treatment only Pregabalin); supplement (thymoquinone)+ standard treatment (pregabalin)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

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

Erbil, IRAQ, 44001, Iraq

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

thymoquinone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer Msc Pharmacology

Model Details: Group one received standard treatment (pregabalin) and group two received standard treatment plus interventional treatment (pregabalin + thymoquinone)

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: July 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)