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临床试验/CTRI/2024/03/063855
CTRI/2024/03/063855尚未招募4 期

Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial - NI

Institute of Medical sciences (IMS) and SUM Hospitalk0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方

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

  • 1-16 years age admitted to the inpatient department
  • 2. Having h/o functional constipation as per ROME IV criteria
  • 3)with Fecal impaction defined as
  • A hard mass in the lower abdomen identified on physical examination or
  • Dilated rectum filled with large amount of stool on per rectal Examination or
  • Excessive stool in the colon on abdominal radiography as determined by a radiologist

排除标准

  • 1) Patients with drug-induced constipation
  • 2) Organic constipation ie,
  • I.Neurological disorders eg. Neural tube defects/cerebral/motor neuron diseases/neuro regression syndromes
  • II.Hirschsprung disease, or anal anomalies
  • III.Known metabolic or endocrine disorders
  • 3) Patients with previous gastrointestinal surgery (except appendectomy)
  • 4) Children with suspected gastrointestinal obstruction
  • 5) Patients taking PEG (either at the time of enrolment or within 2 month before enrolment)
  • 6) Patients receiving medication at enrolment or within 1 month before enrolment influencing gastrointestinal motility function (eg, lactulose, loperamide, cisapride)
  • 7) Known history of Allergy to PEG formulations
  • 8) Patients having comorbidity of any other system like CVS/Respiratory/CNS etc
  • 9)Known case of Chronic kidney disease or history of acute kidney injury in past 3 monthes

研究者

发起方
Institute of Medical sciences (IMS) and SUM Hospitalk

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