A Prospective Interventional Study To Find Out The Efficacy Of Homoeopathic Medicines In The Management Of Constitutional Childhood Obesity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To ascertain the efficacy of homoeopathic medicines in the management of Constitutional obesity in children and assessing improvement of suffering and reduction of obesity by using BMI Scale with MYMOP tool
研究概览
简要总结
Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. A child is considered obese when there is excess accumulation of fat in all subcutaneous tissues and other parts of the body. Obesity is regarded as a pandemic with potential disasters consequences for human health, obesity have its adverse effect on both mental and physical health of the person it can lead to both morbidity and mortality. In most of the children with obesity, environmental factors (95% Cases) is the main etiological factor, most children with obesity do not have any organic causes they are suffering from Constitutional obesity. Only 5% Cases with obesity have organic cause like Endocrinal, Hypothalamic, Drugs Genetic syndrome, Monogenic disorder etc. are suffering from Pathological Obesity
The global prevalence of obesity has doubled from 1990 to 2015. Worryingly, the increase is more in children than in adults. In just three decades, the number of school-going children and adolescents with obesity has increased by 10-fold. The International Association for the Study of Obesity and International Obesity Task Force estimate that 200 million school children worldwide are either overweight or obese. The prevalence of overweight or obesity in Indian children is around 20% leads to significant risk of life style disease in future. The prevalence of overweight and obesity among children and adolescents aged 5-19 has risen dramatically from just 4% in 1975 to just over 18% in 2016 In 2016, more than 1.9 billion adults aged 18 years and older were overweight. Over 340 million children and adolescents aged 5-19 were overweight or obese. In 2019, an estimated 38.2 million children were overweight or obese lived in Asia. It is predicted that by 2025 there will be 17 million obese children in India
In this trial the investigator intend to assess the efficacy of Individualized Homoeopathic Medicine in the management of constitutional childhood obesity**.** InChildren age 5 to 18 year following inclusion and exclusion criteria on 90patients in a single blind, randomized, placebo controlled design in the outpatient of Department of Pediatrics in Government Homoeopathic Medical College & Hospital Ayush Campus, Beside Kaliyasot Dam, Mact Hills, Bhopal – 462003. The patients will be prescribed either Individualized Homoeopathic Medicine or Identical placebo and will be minimum 6 follow up, initially in every 15 days followed by monthly for 12 months. Data will be gathered at base line and after 12 months. Randomization will be computer generated. Assessing improvement of suffering and reduction of obesity by using BMI scale with MYMOP tool. The collected data will be subjected to statistical analysis. The main aim is to ascertain the efficacy of homoeopathic medicines than placebo in the management of Constitutional obesity in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children suffering from constitutional obesity 2.Children 5 to 18 years age group children 3.Obese children using BMI Scale (BMI ≥ 95th percentile or BMI greater than 2 standard deviations above the WHO Growth Reference Data 5 to 19 years of Age) 4.Parents giving consent for child to participate in the study and with regular follow up.
排除标准
- •1.The cases which did not fulfill the inclusion criteria 2.Children having pathological obesity 3.Children who require Emergency, Immune compromised, congenital disease and suffering from other chronic disease including systemic affections of irreversible pathological changes in the body 4.Subjects under the treatment of other system of medicine.
- •5.Parents not giving consent for child to participate in the study and irregular follow up.
结局指标
主要结局
To ascertain the efficacy of homoeopathic medicines in the management of Constitutional obesity in children and assessing improvement of suffering and reduction of obesity by using BMI Scale with MYMOP tool
时间窗: 12 Months
次要结局
- To assess the predisposing factors associated with constitutional obesity among children as per homoeopathic prospective and prevention of obesity and its future complications(12 Months)
研究者
Dr Jay Prakash Tripathi
Jawaharlal Nehru Homoeopathic Medical College
