FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064947 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of underwater massage on high blood pressure patients 
Scientific Title of Study   Immediate effect of neutral underwater massage on autonomic variables among Hypertensive Patients – A Prospective randomized control 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 SHAILY SHARMA 
Designation  POST GRADUATE STUDENT 
Affiliation  MAHARISHI AUROBINDO SUBHARTI COLLEGE AND HOSPITAL OF NATUROPATHY AND YOGIC SCIENCES 
Address  SF 53 Greenwood city Godwin near Godwin Hotel, NH.58, DELHI-HARIDWAR BYPASS ROAD, MEERUT

Meerut
UTTAR PRADESH
250005
India 
Phone  7017439893  
Fax    
Email  shailysharma5027@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NAIR DHIREN AJIT 
Designation  ASSISSTANT PROFESSOR 
Affiliation  MAHARISHI AUROBINDO SUBHARTI COLLEGE AND HOSPITAL OF NATUROPATHY AND YOGIC SCIENCES 
Address  Swami Vivekanand Subharti University Subhartipuram,NH.58, DELHI-HARIDWAR BYPASS ROAD, Meerut UTTAR PRADESH

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 SCIENCES 
Address  Swami Vivekanand Subharti UniversitySubhartipuram,NH.58, DELHI-HARIDWAR BYPASS

Meerut
UTTAR PRADESH
250005
India 
Phone  9448300347  
Fax    
Email  naturopathy@subharti.org  
 
Source of Monetary or Material Support  
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences 
 
Primary Sponsor  
Name  DR SHAILY SHARMA 
Address  SF 53 Greenwood city Godwin Godwin Hotel,NH-58,DELHI-HARIDWAR BYPASS,MEERUT,250005 
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 SHAILY SHARMA  Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences  Swami Vivekanand Subharti University Subhartipuram DELHI HARIDWAR EXPRESSWAY MEERUT 250005
Meerut
UTTAR PRADESH 
7017439893

shailysharma5027@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UECM  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, (2) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL TREATMENT  THE CONTROL GROUP WILL BE GIVEN CONVENTIONAL TREATMENT(RESPECTIVE MEDICINE) 
Intervention  NEUTRAL UNDERWATER MASSAGE   • Pre-operative: The subjects should drink 1-2 glasses of water before and after the procedure. • Operative: The participant should enter the tub once it is filled to the top level. The water will provide movement into the tub through numerous nozzles in such a way as to give a massage. Effleurage, or gentle massaging of muscles and connective tissue, opens this program. The intervention involves massaging the participants body from the soles of their feet to their shoulders. [47] • Time Duration: 20 min. • Temperature: 92-95°  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Primary hypertension
• On regular medication
• Willing to participate in the study
 
 
ExclusionCriteria 
Details  • Female having menstruation
• Mental illness
• Pyrexia
• Participants with a history of secondary hypertension
• Hypertensive complications
• Coronary heart disease
• Pregnancy
• Stroke
• Not willing to participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HRV  PRE AND POST TREATMENT 
 
Secondary Outcome  
Outcome  TimePoints 
Blood pressure (SBP, DBP), Pulse rate, Respiratory rate, Spo2  PRE AND POST TREATMENT 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   20/04/2024 
Date of Study Completion (India) 27/07/2025 
Date of First Enrollment (Global)  20/04/2024 
Date of Study Completion (Global) Date Missing 
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)  

     Hypertension, often called high blood pressure or rising blood pressure, is marked by persistently high blood pressure within the arteries. Blood is circulated from the heart to every part of the body via the vessels. With each beat, the heart pumps blood into the veins. When blood is forced against the walls of blood vessels, or arteries, by the heart, blood pressure is created. When the pressure is higher, the heart has to beat harder.

High blood pressure is another name for hypertension (HTN). It results in several health hazards, such as raising the incidence of stroke and cardiovascular disease, which can cause death.

The prevalence of hypertension has increased, especially in lower- and middle-income countries. In 2010, it was estimated that 1.39 billion people globally (31.1%) suffered from hypertension. Adults with high blood pressure had a higher probability of being in low- and middle-income nations (31.5%), where 1.04 billion people lived than in high-income countries (349 million people), where the prevalence was 28.5%. 

     Men had a slightly greater prevalence of hypertension (18.7%) than women (18.3%). As people age, the incidence of hypertension rises; among those over the age of 65, it was 39.2%.

     The prevalence of prehypertension and hypertension is higher in South Asian individuals aged 18 to 49 in Bangladesh (35.1% and 19.8%), India (43.2 and 14.9%), Nepal (25.2% and 13.8%), and worldwide. In developing South Asian cities, the incidence of prehypertension and hypertension is higher in those with greater financial stability and education rates.

   Approximately 7.5 million deaths annually, or 12.8% of all deaths globally, are related to high blood pressure. It is anticipated that 1.56 billion people will have high blood pressure in 2025. In 2014, the Eighth Joint National Committee (JNC 8) published an evidence-based guideline for the management of high BP in adults these are the guideline recommends the initiation of drug therapy to lower (SBP ≥150 mmHg) or (DBP ≥90 mmHg) at 30 to 59 years of age or older. 

     Risk factors include Inadequate diets (the consumption of excessive amounts of salt, having a diet rich in trans and saturated fats, and consuming minimal fruits and vegetables), being overweight or obese, a lack of physical activity, and using tobacco, smoking, and alcohol.

     Risk factors that cannot be modified include age over 65, a family history of hypertension, and other diseases such as diabetes or renal disease
     The concept of complementary and alternative medicine (CAM), further referred to as "integrative medicine," embraces a wide range of numerous medical and healthcare practices, products, and systems that are nowadays recognized as parts of conventional medicine. Much research has revealed that naturopathy, ayurveda, breathing exercises, yoga, meditation, diet therapy, herbal remedies, acupuncture, spiritual therapies, manipulative therapeutics, homeopathy, and some essential oils are effective complementary and alternative medicine (CAM) therapies for hypertension (HTN)

In the world of science, naturopathy is a well-known complementary and alternative medicine (CAM). It is defined as a drug-free, non-invasive, and evidence-based system of medication that grants medicines with common ingredients dependent on the vitality, toxemia, and self-healing capacity of the body, as well as the standards of healthy living. 

     Maintaining people’s health is the aim of naturopathy. Since it sees the human being as a holistic health unit, it addresses the body’s physiological, psychological, social (moral), and spiritual needs to improve overall health. 
The naturopathic system, which is referred to in complementary and alternative medicine (CAM) as primary health care medicine, is described as a skill, science, philosophy (beliefs), and practice of diagnosis and treatment. To implement its principles, the system used natural resources. A healing force that encourages the body’s innate capacity to heal itself, gets rid of the illness’s root causes and attends to the whole body

     The primary modalities used in naturopathy are hydrotherapy, which includes steam, enema, and body wraps; mud therapy; nutrition and dietetics; fasting therapy; acupuncture; acupressure; reflexology; manipulative therapy; chromotherapy; magnetotherapy; energy healing; behavioral lifestyle interventions; and chelation therapy.

     One of the main treatment techniques widely used in natural medicine is hydrotherapy, sometimes known as water therapy.

     Hydrotherapy is the external or internal use of water in any of its states (water, ice, or steam) to promote health or treat several illnesses with a range of temperatures, pressures, times, and places. Using water in various ways and at varying temperatures can affect various biological systems in a variety of ways. 

     Immersion in water of different degrees of temperature can affect the body by influencing the endocrine system, baroreceptors, thermoreceptors, sympathetic or parasympathetic nervous system, and other systems. These reactions may have an impact on the systems that regulate heart rate and water balance.

     The hydrotherapeutic benefits of immersion baths, which are brought on by hydrostatic pressure, include accelerating metabolism and raising sweat while reducing muscle tension, fever, pain, and emotional repression. Neutral underwater massage is a type of hydraulic massage.

     The temperature of the water is determined to be the most crucial factor in underwater massage. The buoyancy force of water and the hydrostatic pressure of the body in the underwater massage produces a decided stinging sensation at each point of contact, a powerful reflex effect is produced by stimulation of the various sets of nerves which recognize temperature, pressure, pain, and tactile impressions hence various autonomic responses are given following underwater massage of neutral and cold temperature

Although numerous studies have been undertaken to investigate the impact of hydrotherapy on heart rate variability, it is noteworthy that no research has been documented regarding the effect of Underwater massage on heart rate variability among hypertension Consequently, our study is going to address this research gap by examining the effects of underwater massage on heart rate variability in hypertensive individuals.

100 percent data collection has been done

 
Close