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临床试验/CTRI/2025/07/091348
CTRI/2025/07/091348招募中不适用

Effect of honey supplementation in acute diarrhea in children aged 7 months to 5 years.

BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Duration (in hours) from enrolment to last unformed stool

研究概览

简要总结

Acute diarrhea remains a significant cause of morbidity and mortality in children, especially in low- and middle-income countries. The World Health Organization emphasizes oral rehydration therapy (ORS) and zinc supplementation as cornerstones of management. However, there is a growing interest in adjunctive natural therapies that may improve outcomes.

Honey, a natural substance rich in antioxidants, enzymes, and antimicrobial agents, has been used traditionally to treat gastrointestinal illnesses.

Studies suggest that honey:

· Promotes water and electrolyte absorption in the intestine.

· Exhibits bacteriostatic and bactericidal effects against common diarrheal pathogens.

· May help reduce the duration, frequency, and severity of diarrhea.

Yet, evidence on its clinical use in pediatric acute diarrhea remains limited and underexplored. This study aims to assess the effectiveness of oral honey supplementation as an adjunct to standard therapy in children with acute diarrhea

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
7.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Acute non bloody diarrhea (more than or equal to 3 loose stools per day) Age between 7 months and 5 years Mild to moderate dehydration (WHO IMNCI criteria) Informed parental consent.

排除标准

  • Severe dehydration.
  • Malnutrition (weight for height Z score less than 3 standard deviation) H/O Allergy to honey Underlying immunodeficiency or chronic GI disease.

结局指标

主要结局

Duration (in hours) from enrolment to last unformed stool

时间窗: 5 days

次要结局

  • Daily stool frequency(Stool consistency (Bristol Stool Chart))

研究者

发起方
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Gali Tejaswini

BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre

研究点 (1)

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