| CTRI Number |
CTRI/2024/01/061103 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cold foot bath and lavender oil inhalation on blood pressure |
|
Scientific Title of Study
|
Combined effect of cold foot bath and lavender oil inhalation on autonomic variables in healthy volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavya C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady, Dakshina kannada, 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
08123738852 |
| Fax |
|
| Email |
kavyacgowda245@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavya C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady, Dakshina kannada, 574240
KARNATAKA
574240
India |
| Phone |
08123738852 |
| Fax |
|
| Email |
kavyacgowda245@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Dean division of Natural Therapeutics |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
07349424672 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Naturecure
hospital Shanthivana, Dharmasthala, Dakshina kannada, karnataka,574216 |
|
|
Primary Sponsor
|
| Name |
Dr Kavya C |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady, Dakshina kannada, 574240 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavya C |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
Room number 1, First floor, Department of Natural Therapeutics, Shanthivana,
Dharmasthala
Dakshina Kannada
KARNATAKA |
08123738852
kavyacgowda245@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 |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold foot bath |
Cold foot bath: Subjects are asked to sit in a chair or advised to sit on the edge of the bed with backrest and are directed to immerse both legs in a plastic bucket filled with warm water. The temperature of the water is maintained at 18 degree celcius and the duration of the intervention is 20 minutes. 13 liters of water are used and the lower limbs are immersed approximately for 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
Total Duration: 20 minutes |
| Intervention |
Cold foot bath with aroma oil inhallation |
A) Cold foot bath: Subjects are asked to sit in a chair or advised to sit on the edge of the bed with backrest and are directed to immerse both legs in a plastic bucket filled with warm water. The temperature of the water is maintained at 18 degree celcius and the duration of the intervention is 20 minutes. 13 liters of water are used and the lower limbs are immersed approximately for 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
Duration: 20 minutes
B) Aroma oil inhalation: lavender oil inhalation was done during the cold foot bath by using oil diffuser
Duration: 20 minutes
Total duration (cold foot bath with aroma oil inhalation: 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in the study after signing the informed consent form |
|
| ExclusionCriteria |
| Details |
1) Weak and debilitating individuals
2) systemic illness
3) subjects with open wound
4) Had caffeine 2h hours before |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability and Galvanic skin response |
Baseline, During the intervention and 5 minutes after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Heart rate variability (HRV) is an important
tool for assessing cardiovascular function and is a quantitative marker of
autonomic activity, In clinical practice, warm foot baths at 40 °C
have shown a beneficial effect in hypertensive patients and studies have shown that cold pressor tests are capable of modulating autonomicity. The literature shows that aroma oil inhalation was beneficial in reducing stress. So the present study aims to assess the combined effect of cold foot bath and aroma oil inhalation on heart rate variability |