跳至主要内容
临床试验/CTRI/2023/11/060152
CTRI/2023/11/060152尚未招募2/3 期

A Randomized Controlled Clinical Trial to evaluate the efficacy of Bilvadi Panchamoola Churna andGuduchyadi Churna in the management of Sthaulya [Overweight] in children of age group 8 to 15year

Dr Pooja Mahadev Mukadam1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月12日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To study the efficacy of Bilvadi Panchamool churna on body

研究概览

简要总结

Ayurveda have described Sthaulya in Medoroga and Rasapradoshaja vikara . Acharya Kashyapa has considered Sthaulya as one of the aprashasta  sharira during explaining the anthropology.

Acharya Sushruta has considered it as Daruna vyadhi and has established relation of Sthaulya and karshya with quality and production n of rasa dhatu. Bhela Samhita has described it as Medovyapattijanya  Roga . Acharya Charaka has described Sthaulya roga among the astaunindita purusha, Santarapanajanya Vikara, Kapha nanatmaja diseases and Samsodhana yogya vyadhi. Childhood obesity is a known pioneer to obesity and other noncommunicable diseases in later life. Environmental and genetic c factors, lifestyle preferences and culture plays a major role in the increasing prevalence of childhood obesity. WHO defines childhood obesity as one of major public health problem of 21st century  . Obesity means excess accumulation of fat in body . In childhood period if child is significantly overweight for his or her age and height, he/ she suffers from childhood obesity. The estimation n of weight can be done with the help of BMI (body mass index). Weight is earliest parameter used for definition of obesity. After covid pandemic overweight is a serious issue we are finding in children. Obesity may hamper physical and mental growth of children. Children suffer from psychological issues. To overcome all these things it’s need to study on Sthaulya in children. In Modern medical science, drugs are used for obesity which reduces absorption of food or causes suppression of appetite. If we go through Ayurvedic formula which are used in Sthaulya, Guggulu is found to be main ingredient in most of them. But it is also seen that Guggulu is not suitable to all in context to Prakriti, Desha, Kala and age. So there is a necessity to find out substitute. While describing the treatment of Sthaulya, Acharya Charaka emphasized on the use of Ruksha, Ushna and mainly Kapha Vatashamana drugs like Bilvadi Panchmool and use of Madhu for the management of Sthaulya. In Bilvadi Panchmool Churna, there is combination  of five drugs i.e. Bilva. Agnimanth, Gambhari, Patla and Shyonak. Hence the drug has been selected in the management of sthaulya.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
8.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Patients having minimum 4 clinical features of sthaulya as kshudhadhikya, shariragaurava, swedabadh, daurgandha, dourbalya.
  • Age group between 8 to 15 years irrespective of sex and socio economic status
  • Patients having BMI 25 to 29.9
  • Weight more than 85th percentile(i.e.overweight).

排除标准

  • Overweight due to metabolic disorder (Hypothyroidism, Endocrine disorders).
  • Systemic disorders (Congenital Heart Defects, Acute Infectivve Hepatitis and major renal diseases)
  • Known case of inborn error of metabolism.

结局指标

主要结局

To study the efficacy of Bilvadi Panchamool churna on body

时间窗: 60 days study | follow up on 15th 30th 45th 60th day.

weight in the management of Sthaulya for 60 days.

时间窗: 60 days study | follow up on 15th 30th 45th 60th day.

次要结局

  • To observe the adverse effect if any for 60 days.(60 days study follow up on 15th 30th 45th 60th day.)

研究者

发起方
Dr Pooja Mahadev Mukadam
申办方类型
Other []

研究点 (1)

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