Diabetic Peripheral Neuropathy (DPN)Phase 4TQDPNNCT07313111
Thymoquinone as an add-on Therapy for the Management of Patients With Diabetic Peripheral Neuropathy
A Phase 4 study testing stander treatment pregabalin and thymoquinone in people with Diabetic Peripheral Neuropathy (DPN), run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- stander treatment pregabalin and thymoquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2024to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Hawler medical university, Galyawa diabetic center and Neurophysiology department of hawler psychiatric hospital
Erbil, IRAQ, 44001
About this study
Official 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
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?
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- stander treatment pregabalin, thymoquinone
- Keywords
- diabetic neuropathy, thymoquinone, nerve conductive study, oxidative stress
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stander treatment pregabalinDrug
Participants received 75 mg of a pregabalin capsule for two months
thymoquinoneDietary supplement
participants recieved 65 mg of thymoquinone capsule daily for two months
| Study group | Role | What they receive |
|---|---|---|
| Control group (stander treatment only Pregabalin) | Active comparator | Participants in this arm received 75 mg of pregabalin capsule orally for two months Receives: 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 Receives: Drug: stander treatment pregabalin; Dietary Supplement: thymoquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated at base time (before treatment) and two months after treatment
Secondary outcomes (1)
oxidative stress, and inflammatory parameter levels
Measurement of serum Visfatin, Calprotectin, Malondialdehyde, and HbA1c for all participants
Measured: Evaluated at baseline (before treatment) and two months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jul 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group one received standard treatment (pregabalin) and group two received standard treatment plus interventional treatment (pregabalin + thymoquinone)
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Jamal Abdulqadr, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313111
- Sponsor's protocol ID
- HawlerMU-1
- Other IDs
- HawlerMU-TQPG_2025
- Acronym
- TQDPN
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07313111
- Acronym / sponsor ID
- TQDPN / HawlerMU-1
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- diabetic neuropathy, thymoquinone, nerve conductive study, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group one received standard treatment (pregabalin) and group two received standard treatment plus interventional treatment (pregabalin + thymoquinone)
| Arm | Type | Receives |
|---|---|---|
| Control group (stander treatment only Pregabalin) | Active comparator | Drug: stander treatment pregabalinParticipants in this arm received 75 mg of pregabalin capsule orally for two months |
| supplement (thymoquinone)+ standard treatment (pregabalin) | Experimental | Drug: stander treatment pregabalin, Dietary Supplement: thymoquinoneparticipants in this arm received thymoquinone capsule 65 mg + pregabalin capsule 65 mg daily for two months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stander treatment pregabalinParticipants received 75 mg of a pregabalin capsule for two months | Drug | Control group (stander treatment only Pregabalin), supplement (thymoquinone)+ standard treatment (pregabalin) |
| thymoquinoneparticipants recieved 65 mg of thymoquinone capsule daily for two months | Dietary supplement | supplement (thymoquinone)+ standard treatment (pregabalin) |
Primary outcome
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.
1 secondary outcome
oxidative stress, and inflammatory parameter levels
Time frame: Evaluated at baseline (before treatment) and two months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing stander treatment pregabalin and thymoquinone in people with Diabetic Peripheral Neuropathy (DPN), run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral nerve improvement through NCS (time frame: Evaluated at base time (before treatment) and two months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.