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临床试验/CTRI/2024/11/077091
CTRI/2024/11/077091尚未招募4 期

A Comprehensive Study of Growth and Development in Children of Different Prakriti Psycho Somatic Constitution With Special Reference to Malnutrition in Varanasi District.

Institute Of Medical Sciences Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
240
试验地点
1
主要终点
The relation of prakriti with the physical growth and development of the child will be assessed

研究概览

简要总结

It is randomised three groups comparative interventional study to assess the efficacy of the mentioned study in the management of malnutrition. The study aims to conduct the trial on 240 children from the OPD of Ayurvedic Wing of  Banaras Hindu University. The Study includes children between 1 to 3 years of age. The interventional plan is oral in nature. The complete study is divided into 3 groups which are further divided into 3 sub groups comprising: normal, Grade 1 and Grade 2 of malnourishment on the basis of classification given by IAP(Indian Academy of Pediatrics). The interventional Plan will be given after registration and follow up sessions we be conducted every 2 months for a period of 8 months (a total of registration+3 follow ups).

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
1.00 Year(s) 至 3.00 Year(s)(—)
性别
All

入选标准

  • Children should either be underweight or normal. Only mild (grade 1) and moderate level (grade 2) of malnourishment will be included in the study. Age group 1 year.
  • 3 years. Children irrespective of their sex and religion will be included in the study. Written consent of the parent’s for registration of children will be considered.

排除标准

  • Children less than 1 year or more than 3 years.
  • Children who have any life threatening disease or ailment or any congenital anomalies.
  • Feeding other than the oral route.
  • Children with severe (Grade 3) and very severe malnourishment (Grade 4) will be excluded from the study.

结局指标

主要结局

The relation of prakriti with the physical growth and development of the child will be assessed

时间窗: baseline, at 2 months, at 4 months, at 6 months

次要结局

  • Assessment of cognitive development.(Assessment of prakriti.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Prem Shanker Upadhyay

Institute Of Medical Sciences

研究点 (1)

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