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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- peripheral nerve improvement through NCS
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group (stander treatment only Pregabalin)
Participants in this arm received 75 mg of pregabalin capsule orally for two months
干预措施: stander treatment pregabalin (Drug)
supplement (thymoquinone)+ standard treatment (pregabalin)
participants in this arm received thymoquinone capsule 65 mg + pregabalin capsule 65 mg daily for two months
干预措施: stander treatment pregabalin (Drug)
supplement (thymoquinone)+ standard treatment (pregabalin)
participants in this arm received thymoquinone capsule 65 mg + pregabalin capsule 65 mg daily for two months
干预措施: thymoquinone (Dietary Supplement)
结局指标
主要结局
peripheral nerve improvement through NCS
时间窗: 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.
次要结局
- oxidative stress, and inflammatory parameter levels(Evaluated at baseline (before treatment) and two months after treatment)
研究者
Nermin Jamal Abdulqadr
assistant lecturer Msc Pharmacology
Hawler Medical University