| CTRI Number |
CTRI/2025/12/098500 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| 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 Neck cooling on heart rate variability |
|
Scientific Title of Study
|
Effect of targeted carotid cryotherapy on resting cardiovascular parameters in healthy volunteers - A Randomized Controlled Trial |
| 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 Savya A D |
| Designation |
PG scholar |
| Affiliation |
SDM Collee of Naturopathy and Yogic sciences |
| Address |
Department of Natural Therapeutics SDM College of Naturopathy and Yogic sciences
Ujire, Belthangadi, DK
SDM College of Naturopathy and Yogic sciences
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8762455250 |
| Fax |
|
| Email |
savyaad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savya A D |
| Designation |
PG scholar |
| Affiliation |
SDM Collee of Naturopathy and Yogic sciences |
| Address |
Department of Natural Therapeutics SDM College of Naturopathy and Yogic sciences
Ujire, Belthangadi, DK
SDM College of Naturopathy and Yogic sciences
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8762455250 |
| Fax |
|
| Email |
savyaad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasul Das K P |
| Designation |
Assistant Professor |
| Affiliation |
SDM Collee of Naturopathy and Yogic sciences |
| Address |
Department of Natural Therapeutics SDM College of Naturopathy and Yogic sciences
Ujire, Belthangadi, DK
SDM College of Naturopathy and Yogic sciences
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9900910200 |
| Fax |
|
| Email |
dr.prasuldaskp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmsthala Manjunatheshwara Yoga and Nature Cure Hospital - Shantivana Dharmasthala, Belthangady, Dakshina kannada, Karnataka india 574240 |
|
|
Primary Sponsor
|
| Name |
Dr. Savya A D |
| Address |
SDM College of Naturopathy and Yogic sciences
UJIRE
Belthangadi, Dakshina Kannada
574240 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Savya A D |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana |
COE,
DeDepartment of Natural Therapeutics, SDM nature cure and yoga hospital
Shantivana,
Belthangadi, Dakshina Kannada - 574240
Dakshina Kannada
KARNATAKA |
8762455250
savyaad@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 volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plain neck wrap without ice application |
Soft, stretchable cotton clothes of width 8 cm in width and 60 cm in length comfortable wrapped around the neck, wide enough to cover the neck surface. Without the ice application. |
| Intervention |
targeted carotid cryotherapy - Neck wrap with ice application |
Participants will be given with cold compress of 16º Celsius for 5 mins. Soft, stretchable cotton clothes of width 8 cm in width and 60 cm in length comfortable wrapped around the neck, wide enough to cover the neck surface. Ice pack is positioned laterally, over the carotid triangle area on the one side of the neck. Small, flat gel-based ice packs that fit into the pocket, minimizing discomfort or skin damage. Ice packs are restricted only to the carotid area. The neck wrap is designed for 5mins application during resting supine position, ensuring safe and effective vagal stimulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy volunteers
2 Age: 18 to 30 years
3 Both Male and female participants
4 Subjects not on drugs or medication
|
|
| ExclusionCriteria |
| Details |
1 Individuals with acute infectious disease
2 Recent surgery patients
3 Smoking and Alcohol Consumers
4 Individuals with known Cardiovascular and Respiratory Disease
5 Pregnant women
• Weak and debilitating individuals
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability (HRV)
|
T = 0 (Baseline)
T = 1 (immediately after the intervention)
T = 2 (30 mins after intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
T = 0 (Baseline)
T = 1 (immediately after the intervention)
T = 2 (30 mins after intervention)
|
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
10/01/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
My current study will be over carotid cryotherapy, commonly accomplished with a cold compress or cryo-wrap applied around
the neck. When applied to the carotid triangle, this
also targets baroreceptor zones, possibly improving baroreceptor sensitivity.Healthy subjects, between the age
of 18 and 30 years will be identified after obtaining a detailed clinical
history and by performing standard clinical physical examinations.After selecting the eligible
subject’s, recruitment will be done using a computer-generated random number
into two groups.
Group A: Carotid Cryotherapy by
Neck wrap with ice application to Carotid area – 5 mins
Group B: Plain neck wrap without
ice application – 5 mins
Assessment will be
done before and after intervention at time intervals at T = 0,1,2 |