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CTRI Number  CTRI/2024/04/065869 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of neutral spinal spray on hypertension 
Scientific Title of Study   Effect of neutral spinal spray on Autonomic variables among hypertensive patients - A single arm intervention 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  Dr Smriti Goswami 
Designation  Post graduate student 
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science 
Address  1865/4, Indra Nagar 1st, Meerut Uttar Pradesh

Meerut
UTTAR PRADESH
250002
India 
Phone  9536722438  
Fax    
Email  smritigoswami899@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nair Dhiren Ajit 
Designation  Assistant Professor 
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science 
Address  Swami Vivekanand Subharti University, Subharti Puram, NH. 58, Delhi-Haridwar bypass road, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  7899143619  
Fax    
Email  danny.a.nair@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhay M Shankar Gowda 
Designation  Principal 
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science 
Address  Swami Vivekanand Subharti University, Subharti Puram, NH. 58, Delhi-Haridwar bypass road, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9448300347  
Fax    
Email  naturopathy@subharti.org  
 
Source of Monetary or Material Support  
Dr Smriti Goswami 
 
Primary Sponsor  
Name  Dr Smriti Goswami 
Address  1865/4, Indra Nagar 1st, Meerut, Uttar Pradesh (250002) 
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 Smriti Goswami  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science, CSSH, SVSU  Swami Vivekanand Subharti University, Subharti Puram, Delhi-Haridwar bypass, Meerut-250005
Meerut
UTTAR PRADESH 
9536722438

smritigoswami899@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee (Medical)  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 
Intervention  Neutral Spinal Spray  The participants will be instructed to wear a minimum dress, and they will be asked to lie down in a supine position with their entire back supported by a spinal spray tub. There will be a continuous spray from a perforated tube that ascends to the body surface and goes straight to the spinal cord region. The temperature of the water will be measured using a hydratic thermometer (water thermometer). Time duration: 15 minutes. Temperature: 92-95° F 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Pre-diagnosed primary hypertensive subjects
2. Either on or not on regular medication
3. Subjects who are willing to participate after signing the informed consent form 
 
ExclusionCriteria 
Details  1. Subjects using any psychoactive substances, sedatives, anxiolytics, anti-depressants, and consuming alcohol and nicotine
2. Pyrexia due to any reason
3. Diabetic Neuropathy
4. Mental illnesses
5. Subject with open wound
6. Pregnant Women
7. Female subjects during the menstrual cycle because autonomic variables vary during this period 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability (HRV)  Pre and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Pressure (SBP, DBP), Pulse Rate, Heart Rate.  Pre & post intervention 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) 23/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 23/07/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The World Health Organization (WHO) defines hypertension as an excessively high or rising blood vessel pressure condition, with a systolic blood pressure reading of 140 mmHg or more, and a diastolic blood pressure value of 90 mmHg or more. Hypertension is one of the major causes of death and disability worldwide. 

Several studies have shown that naturopathy, ayurveda, breathing exercises, yoga, meditation, diet therapy, herbal remedies, acupuncture, spiritual therapies, manipulative therapeutics, homoeopathy, and the use of certain essential oils are effective CAM therapies for hypertension (HTN). 

Based on the literature authored by Amy Carere, Rob Marc Orr published a paper in the journal Physical Therapy Reviews in September 2016 to determine the impact of hydrotherapy on a patient perceived wellbeing reveals that hydrotherapy can have different impacts on the ANS and CVS depending on the temperature, duration, and mode of water application. There is evidence that thermoneutral water has an antihypertensive impact, which is important for managing and preventing lifestyle disorders including cardiovascular disease (CVD).

In Hydrotherapy, Spinal spraying is a localized hydrating technique that applies a small amount of pressure (1 pressure per square inch, or PSI) and exposes the spinal region to a specified temperature of water for a predetermined amount of time to get the desired results. Since the spinal column is where the majority of nerve roots originate, this process regulates every organ in the body. These include the brain and spinal cord’s sensory, temperature-regulating, vasomotor, sympathetic, and parasympathetic regions. Through improved blood circulation, it enhances the heart’s and lungs’ ability to receive oxygen.

There is a lack of evidence for the mechanism by which hydrotherapy treats various ailments. To understand the mechanism of hydrotherapy and its impact on various conditions more research is required. Therefore, the goal of the study is to assess how promptly neutral spinal spray affects autonomic variables in hypertensive individuals.

Data collection completed.

 
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