| 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
|
|
|
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
|
|
|
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
|
|
|
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. |