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临床试验/CTRI/2024/09/073337
CTRI/2024/09/073337尚未招募1/2 期

EFFICACY OF COLD SITZ BATH ON OBESITY AMONG YOUNG ADULTS - A RANDOMISED CONTROLLED TRIAL

Dr Swaraj Kumar1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月15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
70
试验地点
1
主要终点
1.Body weight

研究概览

简要总结

Obesity, which is defined as an excessive build-up of adipose tissue, is currently a worldwide health epidemic.The term obesity refers to BMI above 30.Recently statistical data show the incidence of obesity is high among the young adults.Recent studies it has shown that exposure to cold water temperature reduces body fat by activating BAT(brown adipose tissue). In the recent past, quite a few studies from several laboratories showed that humans are able to increase their non-shivering thermogenesis capacity due to cold acclimation. The increase in non-shivering thermogenesis goes hand in hand with increases in brown fat presence and activity.There is evidence that stimulating adaptive thermogenesis, defined as the facultative heat produced in response to cold and diet, might serve as a means of preventing or treating obesity . A study had showed that brown-adipose-tissue activity was significantly lower in overweight, there was a significant negative relation between brown-adipose-tissue activity and BMI as well as between brown-adipose-tissue activity and percentage of body fat . A study says that Adaptive thermogenesis by means of prolonged exposure to mild cold and other ways to activate and recruit BAT have emerged as potential tools to combat obesity and its associated metabolic complications, such as insulin resistance .This study was aimed at understanding the effects of cold sitz bath on Body Mass Index, Body weight, Waist circumference, Skin fold thickness and generalized random blood sugar levels among obese individuals.

This study aims to assess the effect of cold sitz bath among young adults of both genders of age group 18 -25 years. A total sample of 70 subjects will be included after screening and randomly divided into 2 groups where the study group (n=35) will be given cold sitz bath and the control group (n=35) will be asked to follow their routine for a period of 24 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 24).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • 1.Willing to participate in the study 2.Obese (Body Mass Index ≥ 30).

排除标准

  • 1.subjects suffering from comorbidities from obesity 2.Alcohol consumption 3.Subject taking other treatment modalites 4.Narcotic drug consumption 5.Subjects with the history of any other systemic illness.

结局指标

主要结局

1.Body weight

时间窗: 1. Pre-assessment - Day 0- Before giving the | intervention. | 2. Post-assessment - Day 24

2.Height

时间窗: 1. Pre-assessment - Day 0- Before giving the | intervention. | 2. Post-assessment - Day 24

3.Waist circumference

时间窗: 1. Pre-assessment - Day 0- Before giving the | intervention. | 2. Post-assessment - Day 24

4.Skin folds thickness

时间窗: 1. Pre-assessment - Day 0- Before giving the | intervention. | 2. Post-assessment - Day 24

5.BMI

时间窗: 1. Pre-assessment - Day 0- Before giving the | intervention. | 2. Post-assessment - Day 24

次要结局

  • GRBS(1. Pre-assessment - Day 0- Before giving the)

研究者

发起方
Dr Swaraj Kumar
申办方类型
Other [self sponser]
责任方
Principal Investigator
主要研究者

Dr Ampasala Swaraj Kumar

Alvas college of Naturopathy and Yogic Sciences

研究点 (1)

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