Comparison of Carbamazepine and Oxcarbazepine In the Treatment of Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Pain relief for TGN
研究概览
简要总结
In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine
详细描述
In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Either gender
- •TGN diagnosis for ≥2 weeks (according to ICHD-3 criteria¹)
- •Exclusion Criteria [Expanded]:
- •Other cranial neuralgias
- •Prior surgical treatment for TN
- •Hepatic/renal dysfunction
- •Pregnant/lactating women
- •Drug allergy or intolerance
- •[Expanded] Uncontrolled hypertension
- •[Expanded] Psychiatric disorders
排除标准
- 未提供
研究组 & 干预措施
Carbamazepine group
In this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management
干预措施: Carbamazepine (Drug)
Oxcarbazepine group
In this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management
干预措施: oxcarbazepine (Drug)
结局指标
主要结局
Pain relief for TGN
时间窗: Two months
Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document.
次要结局
- Side effects(Two months)
研究者
Sikandar Zaidi
Resident (PG R3)
Abbasi Shaheed Hospital