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临床试验/CTRI/2023/06/053458
CTRI/2023/06/053458尚未招募2/3 期

A RANDOMIZED CONTROL STUDY ON ANALYSING THE COMBINED EFFECT OF WARM FOOT BATH WITH COLD SPINAL BATH ON HEMODYNAMIC VARIABLES AMONG HEALTHY INDIVIDUALS

Dr Manju M Y1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月7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
90
试验地点
1
主要终点
Cradiac output, stroke volume, Blood pressure, Total peripheral

研究概览

简要总结

To evaluate the combined effectof warm foot bath withcold spinal bath on hemodynamic variables among healthy individuals and assess:

  1. Cardiac output, Stroke volume, Blood pressure

2. Heart rate variability

Subjects will be recruited from SDM college of naturopathy and yogicsciences, Ujire, Karnataka. A consent form will be obtained from all the participantsafter an appraisal of the study protocol.

Grouping:

·    90 subjects will be randomly allocated into three groupsusing computerized generated randomnumber table, each group contains 30 subjects.

·      Group-1. (n≥30) Cold spinal bath for30 minutes.

·      Group-2. (n≥30) Warm foot bath for 30minutes.

·      Group-3. (n≥30)Warm foot  bath  withcold spinal  bathfor 30minutes.

Methods:

The subjects will be identified. A Signed informedconsent will be obtainedfrom the entire subject afteran appraisal about the study protocol. 90 subjects will be randomly allocated into three groups usingcomputerized generated random number table. Each group containing 30 subjects for group1, cold spinal bath will be given for 30 minutes. Group 2 warm foot bath will be given for 30 minutes, and Group 3 will be taking warm foot bath along with cold spinal bath for 30 minutes. Pre assessments will be done 5minutes before the intervention and post assessments will be 5 minutes after the intervention.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Healthy individuals
  • BMI: 18 -23 kgs/m2.

排除标准

  • Weak and debilitating individuals.
  • Systemic illness.
  • Open wounds.
  • Female subjects during menstruation.
  • Person under any medications during the study.

结局指标

主要结局

Cradiac output, stroke volume, Blood pressure, Total peripheral

时间窗: baseline and 5 min after the | intervention

resistance and Heart rate variability

时间窗: baseline and 5 min after the | intervention

次要结局

  • pulse propagation index(Baseline and 5 min after the intervention)

研究者

发起方
Dr Manju M Y
申办方类型
Other [self]

研究点 (1)

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