跳至主要内容
临床试验/CTRI/2023/07/055149
CTRI/2023/07/055149尚未招募1/2 期

A Randomised Standard Controlled Clinical trail on Bhavitha Triphala Churna in Sthoulya vis-a-vis childhood Overweight and Obesity

DrVaruni P Kulkarni1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月25日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the efficacy of the trial drug with that of standard drug on the values of Body Mass Index Weight Skin Fold Thickness Mid upper arm circumference

研究概览

简要总结

Sthoulya isa condition described under Shleshmananatmajavyadhi (1), Santarpana nimittaja vyadhi(2) and Atibrimhananimittajavyadhi(3). It is described as Upachita shareeratvam(4) and is characterized by excess accumulation of Medas. There are many lakshana of Sthoulya(5) as mentionedin Ayurveda , of which a few symptomsthat are commonly found in children are Atinidra, Alasya, Ayase Shwasa and Atikshudha.

The clinical symptomatology of Sthoulya is similarto that of Overweight and Obesity in contemporary science, which has beendefined as, a body mass index of 23kg/m2 and 27kg/m2 respectively. (Indian cutoffs after 2years of age, which is between 85th to 95thpercentile) (6) Enlargement of fat cell in its size; or anincrease in number of fat cells; or both, leads to abnormal growth of adipose tissue which is known asobesity. In such condition, body fat is extensively accumulated under the skin and around certain organs such as belly,breasts, thighs (7)

  According to a study in 2021, the prevalence ofoverweight and obesity among school children in Mysuru, Karnataka showedthat there was 3.86% of obesity and 12.27% of overweight(8). A recentstudy conducted 2021, in school children of Mysuru, Karnataka revealedsignificant differences in variablessuch as body weight and BMI, before and after lockdown. Post lockdown the BMI increasedamong all the participants from 17.32 to 17.80 kg/m2(p<0.001). The study also depicted thatobesity has a proportional impact on the children’s quality of life (QOL)(9)In a recent study done in Rishikesh ,Uttarakhand, in the year 2021,itwas found that 6.8% of adolescents were obese and that about 17.1% were overweight.(10)These studies give enough proof for the prevalence of overweight andobesity among children even in adolescent age group.

  Some of the common complications of childhood obesity,if left unattended are Obstructive sleep apnea, Asthma,Acanthosis nigricans and Polycystic ovariansyndrome and Psychological problems like Anxiety,Low self esteemand Worsening school performance (11,12). Contemporary science has a multi disciplinary approach in the management of obesity, like lifestyle modification, regular meal timingsand at least 7-8 hours of sleep at night (12).

Ayurveda alsodescribes multi model therapy including diet, medicine and life stylemodifications for Sthoulya. Some of the Shamanoushadhi indicated for Sthoulya are Triphala churna, Vidanga Churna,Vidangadhya louham and Navakaguggulu.(13) Usage of Triphala andMadhu have been specifically mentioned in Sthoulya chikitsa in Charaka Samhita and Ashtanga Samgraha (14). Accordingto the Kerala based text dealing with Kaumarabhritya viz; Arogya Raksha Kalpa Druma

,Triphala trituratedin the Kwatha of Khadira and Asana, consumedfor 1 month reduces Sthoulya. It has been specifically mentionedfor children (15). A previous clinical study conducted in the year of 2011 have shown significant resultsof Khadira and Asana KwathaBhavitha Triphala in children

of 5-15 yearswith Sthoulya in comparison to thecontrol group -Pathya.

 Based on the above references, the present study hasbeen planned to evaluate the efficacy of Bhavita Triphala churna in Sthoulya viz a viz childhood overweightand obesity in adolescent children.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
10.00 Day(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects from age group 10-16 years, irrespective of gender and socioeconomic status.
  • 2.Obesity caused due to Exogenous factors like over-eating and poor physical activities.
  • 3.Body mass index of 23kg/m2 and27kg/m2 respectively i.e. body weight between 85th -95th percentile for the selected age group.
  • 4.Subjects having signs and symptoms of Sthoulya as explained in Ayurveda.
  • 5.Parents ready to sign written informed consent.

排除标准

  • 1.Known cases of endocrine disorders like Hypothyroidism and Cushing’s syndrome.
  • 2.Any other systemic and genetic disorders.
  • 3.Drug induced obesity.

结局指标

主要结局

To compare the efficacy of the trial drug with that of standard drug on the values of Body Mass Index Weight Skin Fold Thickness Mid upper arm circumference

时间窗: 6 months

次要结局

  • To compare the efficacy of trial & standard drugs on Health Related Quality Of Life(HRQoL) parameters(70 days)

研究者

发起方
DrVaruni P Kulkarni
申办方类型
Other []

研究点 (1)

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