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临床试验/CTRI/2009/091/000053
CTRI/2009/091/000053已完成2 期

Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial.

AIIMS0 个研究点目标入组 96 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
AIIMS
入组人数
96

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: 2 ? 14 years.
  • 2) Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.

排除标准

  • 1)Known or suspected inborn error of metabolism:
  • 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
  • With or without 2 or more of the following biochemical abnormalities
  • High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (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

发起方
AIIMS

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