CompletedPhase 4

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

Iraq50 participantsStarted 2024-07-01

Plain-language 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?

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

peripheral nerve improvement through NCS

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

Trial details

NCT IDNCT07313111

SponsorHawler Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy (DPN) trials