跳至主要内容
临床试验/CTRI/2023/07/055188
CTRI/2023/07/055188尚未招募3 期

Evaluation of the efficacy of Ayush-BR Leham in the management of Moderate malnutrition among children aged 3-5 years – A Multicenter Randomized Controlled Pilot study trial

Central Council for Research in Ayurvedic Sciences2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月8日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
200
试验地点
2
主要终点
Proportion of participants attaining a change in weight for age z score by 0.5 or more as per WHO reference standards

研究概览

简要总结

Malnutrition from a worldwide perspective, is one of the leading causes of mortality and morbidity in childhood. Under weight among under five children ranges from 39%-75% in different parts of the country. Prevalence of undernutrition among under-five children according to NFHS 4 (2015-16) in India shows that 35.7% were underweight, 38.4% were stunted and 21% were wasted. Undernutrition kills or disables millions of children every year and prevents millions of children reaching their full potential. Under nutrition is associated with impaired immune function and consequent increased susceptibility to infections; infections aggravate undernutrition; if this vicious cycle continues it can even result in death of the child. Early detection of malnutrition is essential in under-five children, so that timely interventions can be planned and implemented at the community level. So, it is the need of the hour to tackle this problem for better growth and development of the child with good immunity.

Nutrition in early childhood plays an important role in bringing positive health outcomes in children. Nutritional status of children can be considered as a proxy indicator of community’s health status. Low per capita income, poor environment sanitation, diseases, infections, inadequate access to primary health care, inappropriate childcaring and feeding practices in majority of Indian families leads to undernutrition of children and also affects their physical and mental development. Although different intervention programs are implemented in India to tackle this problem, no significant reduction has been observed in the burden of under-nutrition in under-ï¬ve children.

According to Ayurveda, malnutrition in children is explained under various terminologies viz: Kumarasosha, Phakka, Parigarbhika, Karshya etc. All these disease conditions have agnimandya (impaired digestion and metabolism) and srotorodha (obstruction in body channels) leading to dhatu sosha (undernourished tissues) as the underlying pathology. Here primary emphasis should be given to correction of agni (digestion and metabolism) and srotorodha by deepana, pachana drugs (drugs correcting digestion and metabolism) followed by improving the quality and quantity of dhathus by brimhana (nourishing) therapy. This will improve the nutritional status, bestow immunity and good health to the child thereby preventing further infections. Such a treatment protocol may provide a sustained effect in the growth of the child. The present study is intended to study the effect of Ayush-BR leham in children with moderate malnutrition aged 3-5 years. Prior to the administration of Ayush BR leham, Aravindasava which is having Deepana pachana properties is given in both groups. The ingredients in Ayush-BR leham is having brimhana and antimicrobial properties which may help in improving anthropometric parameters and immunity of the child.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Children of age group between 3-5 years
  • Children with weight for age between -2 and -3 SD of the World Health Organization weight for age growth standards
  • Parents or caregivers willing to provide a written informed consent form for the participation of their children.

排除标准

  • Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery
  • Children with acute infections viz- respiratory tract infections, diarrhoea, fever etc
  • History of hypersensitivity to the trial drug or any of its ingredients
  • Patients who have completed participation in any other clinical trial during the past six months
  • Any other condition which the Investigator thinks may jeopardize the study.

结局指标

主要结局

Proportion of participants attaining a change in weight for age z score by 0.5 or more as per WHO reference standards

时间窗: Time frame 16 weeks | assessment at baseline & 12th week followed by assessment at 16th week

次要结局

  • Changes in the anthropometric measurements (weight, height, BMI, mid upper arm circumference)(Time frame 16 weeks – assessment at baseline, every 2 weeks in the first 12 weeks followed by assessment at 16th week)
  • Change in the frequency of illnesses(Time frame 16 weeks – assessment at the baseline, 12th week & 16th week)
  • Safety parameters assessed on the basis of biochemical parameters(Time frame 12 weeks – assessment at the baseline, 12th week)

研究者

申办方类型
Research institution

研究点 (2)

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