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临床试验/NCT06529497
NCT06529497尚未招募1 期

Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone

Liaquat National Hospital & Medical College0 个研究点目标入组 260 人开始时间: 2024年8月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
260
主要终点
Stool frequency

研究概览

简要总结

Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.

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
3 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Hospitalized Patients with acute watery diarrhea of both genders who are
  • Age: 03 months to 05 years
  • Present in first 24 hours of onset of disease.

排除标准

  • Parenteral Diarrhea
  • Chronic Diarrhea like Coeliac disease, Lactose intolerance
  • Mal-absorption Syndromes
  • Diarrhea related to food poisoning, dysentery as suggested by history
  • Severe dehydration patents who are vitally unstable.
  • Diarrhea associated with measles.
  • Persistent vomiting
  • Abdominal distention
  • Patients allergic to racecadotril
  • Patients managed before enrolled to study

研究组 & 干预措施

treatment group receiving (racecadotril+ORS+Zinc)

Experimental

The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone

干预措施: Racecadotril (Drug)

the control group (receiving ORS + Zinc or standard treatment)

Active Comparator

The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone

干预措施: Racecadotril (Drug)

结局指标

主要结局

Stool frequency

时间窗: 48 hours

Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups

次要结局

  • Hospital Duration(48 Hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aqsa Jabeen

Consultant

Liaquat National Hospital & Medical College

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