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临床试验/CTRI/2024/05/067137
CTRI/2024/05/067137已完成2/3 期

Impact of cold douche to abdomen on gastric myoelectrical activity and autonomic variables in healthy young adults

Dr Mithun A C1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月6日最近更新:
适应症
相关药物

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Gatric motility and Heart rate Variablity

研究概览

简要总结

Douche is a hydrotherapeutic modality which uses water application with pressure to desired body parts using a single or multiple columns of water. In the therapeutic employment of the douche, active three factors are: temperature, pressure and duration . Anecdotal studies show that cold abdominal douche can be helpful in managing the altered gastric motility. It is essential to understand the underlying mechanisms before applying them as a theraputic agents. So the present study was designed to assess the influence of cold douche to abdomen on gastric myoelectrical activity.

Grouping

30 healthy subjects will be assessed at 2 times with a wash out period of 2 days by dividing into 2 groups with equal number

2 Groups

Group 1 (n=15)

Group 2 (n=15)

The institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention after an appraisal about the study protocol. All the rights of the individual pertaining to the study will be explained to the individual in their convenient language.

after selecting the elegible subjects. Allotment will be done by using a computer generated random number

Day 1: Subject 1- Cold douche to abdomen(5min)

Subject 2- neutral douche to abdomen

Day 4: Subject 1- neutral douche to abdomen(5min)

Subject 2- Cold douche to abdomen(5min)

Assessments will be done before and after intervention at time intervals at T= 0,1,2,3

T= 0(baseline)

T= 1(immediately after the intervention)

T= 2(30minutes after intervention)

T= 3(1hr after intervention)

th

t

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • •subjects who are willing to participate in the study after signing the informed consent form.

排除标准

  • •1 Weak and debilitating individuals 2 Any medical illness/ taking medications 3 Recent surgeries 4 Smokers and alcoholics 5 Caffeine intake before 24 hours.

结局指标

主要结局

Gatric motility and Heart rate Variablity

时间窗: baseline, immediately after intervention, 30min after intervention and 1hr after intervention

次要结局

  • •To quantify the change in dominant power and dominant frequency of gastric motility induced by cold douche to abdomen.(•To assess the percentage of change in normogastric, bradygastric and tachygastric waves.)

研究者

发起方
Dr Mithun A C
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mithun A C

Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire

研究点 (1)

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