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

December 17, 2025 updated by: Nermin Jamal Abdulqadr, Hawler Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Evaluated at base time (before treatment) and two months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Evaluated at baseline (before treatment) and two months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hawler Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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