| CTRI Number |
CTRI/2026/01/100297 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of ice-cold arm bath for people with headache |
|
Scientific Title of Study
|
Effect of ice-cold arm bath on heart rate variability in individual with migraine - A quasi experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Gautam |
| Designation |
UG Scholar |
| Affiliation |
|
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8209073770 |
| Fax |
|
| Email |
parulgautam345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul Gautam |
| Designation |
UG Scholar |
| Affiliation |
|
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8209073770 |
| Fax |
|
| Email |
parulgautam345@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Gautam |
| Designation |
UG Scholar |
| Affiliation |
|
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire Belthangady taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8209073770 |
| Fax |
|
| Email |
parulgautam345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara nature cure hospital shantivan,Dharmasthala Dakshina Kannada ,Karnataka-574240,India. |
|
|
Primary Sponsor
|
| Name |
Parul Gautam |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire ,Belthangady taluk, Dakshina Kannada ,Karnataka-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 Sujatha K J |
SDM Nature cure and Yoga hospital shantivana |
COE Dept of Research, SDM Nature cure and yoga Hospital shantivana, Dharmasthala belthanagady 574240
Dakshina Kannada
KARNATAKA |
9480401646
drsujathadinesh2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and yogic sciences Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of ice-cold arm bath |
Effect of ice-cold arm bath on heart rate variability in individuals with migraine a quasi-experimental study |
| Intervention |
Ice cold arm bath |
Application of ice cold arm bath for 7 days with duration of 3-5 minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects who satisfy the ICHD3 diagnostic criteria migraine without aura or Migraine with aura
2 Subjects who do not have other arm injuries and deformities
3 Willingness to participate in the research and provide informed consent |
|
| ExclusionCriteria |
| Details |
1 Underlying sinusitis trigeminal neuralgia
2 Severe cold sensitivity hypoesthesia
3 Individuals with recent surgeries traumatic injuries or infection
4 History of mental illnesses
5 Subjects with a history of alcohol and substance abuse. |
|
|
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 |
| Effect of ice-cold arm bath on heart rate variability parameters |
Baseline at day 1, last day of the intervention on 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain modulation using,Migraine disability assessment test,visual analogue scale,migraine specific quality of life questionnaire |
Baseline at day 1, last day of the intervention on 7th day |
|
|
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)
|
23/01/2026 |
| 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="1"
Months="0"
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
|
The primary aim is to investigate the effect of a 7-day course of ice-cold arm baths on Heart Rate Variability an objective measure of Autonomic Nervous System activity in subjects diagnosed with migraine Secondary objectives include assessing pain modulation migraine-related disability and Migraine Specific Quality of Life Subject Area Hydrotherapy Naturopathy and Yoga Participants bm n 30 subjects 18-50 years both genders with migraine recruited based on ICHD-3 and ID Migraine criteria intervention Ice-cold arm bath 4-5°C for 3-5 minutes administered daily for a total duration of 7 days Assessments Measurements are taken pre- and post-intervention Objective Measure Heart Rate Variability •Subjective Measures Visual Analogue Scale Migraine Disability Assessment Test and Migraine-Specific Quality of Life Questionnaire |