| CTRI Number |
CTRI/2023/06/053458 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Combined effect of warm foot bath with cold spinal bath on hemodynamic variables among healthy individuals |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL STUDY ON ANALYSING THE COMBINED EFFECT OF WARM FOOT BATH WITH COLD SPINAL BATH ON HEMODYNAMIC VARIABLES AMONG HEALTHY INDIVIDUALS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju M Y |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady,
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8546974385 |
| Fax |
|
| Email |
manjumym682@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju M Y |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady,
KARNATAKA
574240
India |
| Phone |
8546974385 |
| Fax |
|
| Email |
manjumym682@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean division of Nutrition and Dietetics |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr Manju M Y |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady, Dakshina kannada 574240 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju M Y |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
Department of Natural Therapeutics, Shanthivana,
Dharmasthala
Dakshina Kannada
KARNATAKA |
08546974385
manjumym682@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold spinal bath |
Cold Spinal bath tubs are made up of fiber material and are water proof and non-allergic. The dimension of the spinal bath tub is 3x21/2 and the height is 10 inches. The temperature of the water in the spinal bath is 13-18°C (55-65°F). Water temperature is measured by using a digital thermometer. The subject’s lies down in a spinal bath tub with minimum dress, with the head on the side that is most slanted, his buttocks at the opposite side end and his feet outside and adjusts himself to the water of the tub such that water should touch the entire length of the spine, from the nape of the neck to the lowest portion of the spine. Intervention will be given for 30 minutes.
|
| Comparator Agent |
Warm foot bath |
Subjects are asked to sit in a chair or advised to sit on the edge of the bed with a backrest and are directed to immerse both legs in a plastic bucket filled with warm water. The water temperature is maintained at 400C(1040F) and the duration of the intervention is 30 minutes. 13 liters of warm water are used and the lower limbs are immersed approximately 20 cm from the sole of the foot to above completely covering the calf muscles. After the completion of foot bath the water is wiped off with a towel. |
| Intervention |
Warm foot bath along with cold spinal bath |
A combined treatment of warm foot bath with cold spinal bath in which the patient will be taking warm foot bath at 400C (104 0F) with cold spinal bath at 13-18°C (55-65°F) for duration of 30 minutes. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy individuals
2. BMI: 18 -23 kgs/m2 |
|
| ExclusionCriteria |
| Details |
1. Weak and debilitating individuals.
2. Systemic illness.
3. Open wounds.
4. Female subjects during menstruation.
5. Person under any medications during the study |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cradiac output, stroke volume, Blood pressure, Total peripheral
resistance and Heart rate variability |
baseline and 5 min after the
intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pulse propagation index |
Baseline and 5 min after the intervention |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
To evaluate the combined effect of warm foot bath with
cold 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 yogic
sciences, Ujire, Karnataka. A consent form will be obtained from all the participants
after an appraisal of the study protocol. Grouping: · 90 subjects will be randomly allocated into three groups
using computerized generated random
number table, each group contains 30 subjects. ·
Group-1. (n≥30) Cold spinal bath for 30 minutes. ·
Group-2. (n≥30) Warm foot bath for 30 minutes. ·
Group-3. (n≥30)
Warm foot bath with
cold spinal bath
for 30 minutes. Methods:
The subjects will be identified. A Signed informed
consent will be obtained
from the entire subject after
an appraisal about the study protocol. 90 subjects will be randomly allocated into three groups using
computerized 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.
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