A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
研究概览
简要总结
Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
详细描述
The trial will be comparing the effectiveness of short and long duration of albendazole ie 7 and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete resolution or calcification of cyst on CT head at the end of 6 months after starting albendazole
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-18 years.
- •Number of parenchymal lesions: upto 5*
- •Stages of cysticerci at which albendazole treatment is effective
- •Vesicular stage
- •Colloid vesicular stage
- •Granular nodular stage
排除标准
- •Cysticercotic encephalitis
- •Calcified cyst
- •Hydrocephalus
- •Intraventricular cyst
- •Subarachnoid cyst
- •Ophthalmic Cysticercosis
- •No of cysts >5
- •Known allergy to benzimidazole class of compound which includes anaphylaxis, hypotension, severe skin reactions .
- •Features of raised ICT (papilloedema, hyperventilation, hypertension, tonic posturing, B/L 6th nerve palsy, features of midline shift on CT/MRI)
- •Critically sick (respiratory failure, cardiovascular instability)
- •Already received albendazole or praziquantel or steroid therapy
研究组 & 干预措施
Group A
7 days of albendazole 15 mg/kg/day
干预措施: 7 days of albendazole 15 mg/kg/day (Drug)
Group B
28 days of albendazole 15 mg/kg/day
干预措施: 28 days of albendazole 15 mg/kg/day (Drug)
结局指标
主要结局
Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
时间窗: 1 year
A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load \< 5
次要结局
- Frequency of seizure occurrence(1 year)
- Frequency of occurrence of other symptoms attributable to Neurocysticercosis(1 year)
- Frequency of occurrence of side effects of albendazole(1 year)
研究者
Sheffali Gulati
Additional professor, dept of Pediatrics
All India Institute of Medical Sciences, New Delhi