跳至主要内容
临床试验/CTRI/2019/08/020693
CTRI/2019/08/020693尚未招募2 期

Clinical study to evaluate the efficacy of chavyadi shaktu for weight management management in stholya w.s.r.to overweight in children.

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the role of Chavyadi shaktu in Childhood stholya

研究概览

简要总结

Obesity is a condition where a person has accumulated so much body fat, it might have a negative effect on their health and increases the risk of other metabolic disorders such as type 2 diabetes, insulin resistance, hypertension, dyslipidaemia,  inflammation, thrombosis, obstructive sleep apnoea, cardiovascular disease, some cancers and mortality.1,2 Obesity  caused by several factors viz., social and environmental status, genetics factors, and individual preferences like age, gender, high energy and less nutrient diet pattern, regular intake of excess calories and fatty foods, lack of physical activity.3 The changeover of a rural to an urban lifestyle that is a major cause of obesity e.g. increased intake of high energy dense foods and decrease in physical activity.

Adults having body mass index (BMI) greater than or equal to 25 and 30 considered overweight and obese, respectively while in the reference of children 85th percentile and 95th percentile of BMI considered overweight and obese, respectivelyand it is increasing at an alarming rate throughout the globe. According to WHO the worldwide obesity has nearly tripled since 1975 and over 340 million children and adolescents aged 5-19 were overweight or obese in 2016.  In 2016, an estimated 41 million children under the age of 5 years were overweight or obese. Nearly half of the children under 5 who were overweight or obese in 2016 lived in Asia. The prevalence of overweight and obesity among children and adolescents aged 5-19 has risen dramatically from 4% in 1975 to over 18% in 2016. The rise has occurred similarly among both boys and girls. While less than 1% of children aged 5-19 year were obese in 1975, 6% of girls and 8% of boys were obese in 2016.5 The prevalence of obesity among school children in India has found between 5.74% and 8.82% and approximately 21.4% of boys and 18.5% of girls were obese in the 13-18 years age group in urban regions of South India.

In present trend of clinical practice we need to justify and prove the clinical efficacy of classical formulations on scientific parameters so Chavyadi shaktuas mentioned in Bhaishjya Ratnawali is proposed to evaluate the efficacy and utility in the treatment of obesity in children.

  1. To assess the efficacy of Chavyadi Shaktuin the weight managemen in the stholya w.s.r. to obse children

  2. To restore normal physical activity and to promote the healthy life style of  stholya  w.s.r. to obese children.

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
10.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Age between 10-15 years will be selected.
  • Children with Familial tendency of obesity.
  • Obesity due to sedentary lifestyle and dietary habits.
  • Children having BMI between 85th to 95th percentile of CDC growth charts 2000.

排除标准

  • Children those are suffering from any systemic and endocrinal illness like DM, Hypothyroidism etc.
  • Obesity associated with chromosomal disorders/metabolic disorders.
  • Children those are already on treatment for obesity or other disorders.
  • Drug induced obesity.

结局指标

主要结局

To evaluate the role of Chavyadi shaktu in Childhood stholya

时间窗: 60 Days

次要结局

  • To restore normal physical activity and to promote the healthy life style

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Government medical college

研究点 (1)

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