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临床试验/CTRI/2010/091/002944
CTRI/2010/091/002944已完成2 期

Evaluation of reflexology as an adjunctive therapy in children with refractory Childhood Epilepsy including West Syndrome

All India Institute of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
60

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

  • 1. Age: 6 months to 12 years
  • 2. Presence of seizures persisting daily or more than 7 per week despite the adequate trial of at least three tolerated and appropriately chosen and used anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin.
  • 3. Residents of Delhi/National capital region.

排除标准

  • 1.Known or suspected inborn error of metabolism, as evidenced by:
  • Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination
  • And/ or 2 or more of the following biochemical abnormalities
  • High blood ammonia ( >80mmol/L), High arterial lactate ( >2 mmol/L), metabolic acidosis (pH <7.2), hypoglycemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
  • 2.Motivational or psychosocial issues in the family which would preclude compliance.
  • 3.Systemic illness- chronic hepatic, renal or pulmonary disease.

研究者

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