CTRI/2017/12/010742已完成4 期
Effectiveness and Safety of high dose, Oral Pyridoxine as add on to ACTH versus ACTH therapy for Infantile Spasms: A randomised, Open-Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Infantile spasm patients diagnosed clinically and by EEG
- •Age 3to18 months
排除标准
- •Proven/ suspected case of Tuberous Sclerosis
- •b) Proven/suspected case of neurometabolic, neurodegenerative or any other progressive disorder
- •c) Previously treated patients with ACTH, oral steroids (within 28 days) and pyridoxine
- •d) Contraindications to ACTH and pyridoxine therapy like cushingoid state, fever, diarrhea, hypertension
- •e) Inability of parents/guardians to provide informed consent
- •f) Inability of parents/guardians to provide data of outcome of spasms
研究者
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