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临床试验/CTRI/2023/11/059581
CTRI/2023/11/059581尚未招募1 期

Effectiveness of Amylase Rich Food in children with diarrhea

未提供1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年12月11日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
180
试验地点
1
主要终点
Primary outcomes will be frequency and volume of diarrhea episode experienced by children in each group.

研究概览

简要总结

The question always remains what more can be done to treat children with diarrhea. Some superfoods which would remove toxin from gut, decreases damage to gut mucosa, aid in healing and promote gut regeneration. Challanges of treating dehydration have been overcome with WHO guidelines.

Food availability in resource poor setting is of major concern. While food acceptability and palatability are of concern to primary caregiver of child. To overcome above obstacles, Ragi based Amylase Rich Food was selected in present study.

All infant and young children with diarrhea would be given treatment for dehydration and diarrhea as per WHO protocol while 50% of cases would be given in addition S.P. formula. S.P. formula would be made as follows.

To 70ml of portable drinking water ,10Gms of puffed rice powder would be added, mixture will be boiled at 100 degrees Celsius for 30 secs on induction heater, to this 10Gms jaggery will be added and again mixture will be boiled at 100 degrees Celsius or 30secs. Vessel will then be removed from the heater and stirred for 30sec. To this 7Gms of Ragi based Amylase Rich Food will be added. In sometime mixture starts liquifying, releasing a pleasant aroma. This S.P. formula will be given to treatment group. Effect will be studied with respect to following.

Effect on frequency and duration of diarrhea, consistency of stool, acceptability of feeds, effect on weight gain in child, appearance of any complication and duration of hospital stay, duration of injectable therapy(antibiotics/fluid) .

The above mentioned S.P. formula is going to be prepared at Nutritional Rehabilitation Centre, Sassoon hospital under aseptic and hygienic condition.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
7.00 Month(s) 至 36.00 Month(s)(—)
性别
All

入选标准

  • Children of age 7 months to 36 months with diarrhea.

排除标准

  • Children requiring ventilatory support.

结局指标

主要结局

Primary outcomes will be frequency and volume of diarrhea episode experienced by children in each group.

时间窗: Till resolution of diarrhea.

次要结局

  • secondary outcomes will include weight gain by children, time to first formed stools, acceptability of daily feeds and overall well-being(Till resolution of diarrhea.)

研究者

发起方
未提供

研究点 (1)

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