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CTRI Number  CTRI/2024/12/078780 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 28/12/2024
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 Hot Arm and Foot Bath in Hypertension Patients 
Scientific Title of Study   Immediate Effect of Hot Arm and Foot Bath on Autonomic Variables in Hypertensive Patients - A Prospective 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 Charulatha K T K 
Designation  PG Scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences Ujire 
Address  Department of Naturopathy Clinical SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi Dakshina Kannada - 574240 Karnataka India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9108460835  
Fax    
Email  drcharulathaktk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charulatha K T K 
Designation  PG Scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences Ujire 
Address  Department of Naturopathy Clinical SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi Dakshina Kannada - 574240 Karnataka India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9108460835  
Fax    
Email  drcharulathaktk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujatha KJ 
Designation  Dean Division of Natural Therapeutics and Vice principal of SDMCNYS 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  Department of Naturopathy Clinical SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi Dakshina Kannada - 574240 Karnataka India

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9480401646  
Fax    
Email  drsujathadinesh2@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana Dharmasthala Belthangadi Dakshina Kannnada - 574216 
 
Primary Sponsor  
Name  Dr Charulatha K T K 
Address  SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi Dakshina Kannada - 574240  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Charulatha K T K  Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana  COE Department of Naturopathy Clinical Shantivana Dharmasthala Belthangdi Dakshina Kannada - 574216
Dakshina Kannada
KARNATAKA 		 9108460835

drcharulathaktk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20 minutes of sitting  The control group will be given 20 minutes of sitting, crossed hands and forward bent alone (without water immersion). Duration of intervention:20 minutes 
Intervention  Hot Arm and Foot Bath  The subjects will be asked to be in sitting position with minimal dress and Subjects are instructed to drink a glass of tepid water. The subjects will be asked to immerse their both upper limbs (Fingers, hands, wrist joints, forearms and elbow joints) and both lower limbs (Toes, foot, ankle joints and half of the legs till the origin of the Achilles tendon) in the specially prepared tub filled with hot water (38–40 °C) for the duration of 20 min. The intervention will be in the evening between 4 pm and 7:00 pm. The temperature of the water will check for every 5 min interval using water thermometer. If, reduction in temperature found below 38 °C, addition of hot water will be employed (only one time between 10th and 15th min of intervention) to maintain the temperature within the desired range Duration of intervention : 20 minutes 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age:30-60years
2. Gender: Male and Female
3. Systolic blood pressure (SBP) ≥140 mmHg and/or a diastolic blood pressure (DBP)≥90 mmHg; with or without antihypertensive drugs

 
 
ExclusionCriteria 
Details  1. Renal disease
2. History of heart attack.
3. History of stroke or transient ischemic attack.
4. Congestive heart failure.
5. Severe liver disease.
6. Pregnancy or lactation period.

 
 
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 
Heart rate variability  Baseline
Immediately after intervention(Post intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Pressure  Baseline
Immediately after the Intervention(Post intervention) 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 
Date of First Enrollment (India)   15/01/2025 
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 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   Clinically there was no significant study conducted  on hot arm and foot bath on autonomic variables. Hence, the present study is designed to evaluate the immediate effect of hot arm and foot bath on heart rate variability in hypertensive individuals.  
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