Efficacy and Safety of Oral Antiviral Drug Combined With Carbamazepine Versus Celecoxib Combined With Carbamazepine in the Treatment of Idiopathic Trigeminal Neuralgia: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Changes in Visual Analogue Scale (VAS) Pain Score
研究概览
简要总结
This is a multicenter, prospective, randomized, controlled trial. A total of 165 patients with idiopathic trigeminal neuralgia will be enrolled and randomly divided into three groups at a 1:1:1 ratio. The aim is to compare the efficacy and safety of conventional carbamazepine monotherapy, carbamazepine combined with oral antiviral therapy, and carbamazepine combined with anti-inflammatory therapy in pain relief, quality of life improvement and adverse event profiles.
详细描述
Idiopathic trigeminal neuralgia is a severe neuropathic pain disorder. Carbamazepine is the first-line conventional treatment, but some patients have insufficient pain relief or intolerable side effects. Viral latent infection and neuroinflammation are considered potential pathogenesis of trigeminal neuralgia. This study intends to explore whether adding oral antiviral agent (acyclovir) or non-steroidal anti-inflammatory drug (celecoxib) can further improve pain control, reduce carbamazepine consumption, improve mood status and quality of life, and ensure clinical safety. All participants will receive 12-week standardized treatment and follow-up at 1 week, 2 weeks, 1 month, 3 months and 6 months after enrollment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic trigeminal neuralgia according to standard clinical criteria.
- •No secondary etiology confirmed by cranial imaging.
- •No severe systemic disease or immune system disease.
- •Voluntary participation and signed informed consent.
排除标准
- •Secondary trigeminal neuralgia of any cause.
- •Active herpes zoster infection recently.
- •Severe hepatic or renal insufficiency or contraindications to study drugs.
- •Unable to complete questionnaire evaluation independently.
- •Pregnancy or lactation state. -
研究组 & 干预措施
Arm A：Control Group（Carbamazepine Monotherapy）
Intervention：Drug: Carbamazepine Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
干预措施: Intervention：Drug: Carbamazepine (Drug)
Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir）
Intervention：Drug: Carbamazepine + Acyclovir Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
干预措施: Intervention：Drug: Carbamazepine + Acyclovir (Drug)
Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib）
Intervention：Drug: Carbamazepine + Celecoxib Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
干预措施: Intervention：Drug: Carbamazepine + Celecoxib (Drug)
结局指标
主要结局
Changes in Visual Analogue Scale (VAS) Pain Score
时间窗: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment
Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score.
次要结局
- Average Daily Carbamazepine Consumption(1 week, 2 weeks, 1 month, 3 months)
- Adverse Event Incidence(Throughout 12-week treatment and follow-up period)
- Quality of Life (SF-36) Score(1 week, 2 weeks, 1 month, 3 months)
- Anxiety and Depression Score (HADS)(1 week, 2 weeks, 1 month, 3 months)
研究者
Fang Luo
Department of Pain Medicine
Beijing Tiantan Hospital