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CTRI Number  CTRI/2023/07/055913 [Registered on: 31/07/2023] Trial Registered Prospectively
Last Modified On: 29/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparative Study Of Immediate Effect Of Cervical Ice Massage And Acupuncture In Autonomic Variables And Blood Pressure In Hypertensive Individuals 
Scientific Title of Study   Immediate Effect Of Acupuncture And Acupuncture With Wervical Ice Massage On Autonomic Variables And Blood Pressure In Hypertensive Individuals - A Comparative Study 
Trial Acronym  Clinical Trial Registration 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aadhithyan P S 
Designation  Doctor 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences , Ujire. 
Address  Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences , Ujire.

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7349203918  
Fax    
Email  aadhithya10145@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashikiran H C  
Designation  Dean Divison Of Research Methodologies And Deputy Medical Superindent 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences 
Address  Dr Shashikiran H C , Deputy Medical Superinident ,Sri Dharmasthala Manjunatheswara Yoga And Naturecure Hospital, Shanthivana,Dharmasthala

Dakshina Kannada
KARNATAKA
574216
India 
Phone  9483004440  
Fax    
Email  bnysresearch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shashikiran H C  
Designation  Dean Divison Of Research Methodologies And Deputy Medical Superindent 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences 
Address  Dr Shashikiran H C , Deputy Medical Superinident ,Sri Dharmasthala Manjunatheswara Yoga And Naturecure Hospital, Shanthivana,Dharmasthala

Dakshina Kannada
KARNATAKA
574216
India 
Phone  9483004440  
Fax    
Email  bnysresearch@gmail.com  
 
Source of Monetary or Material Support  
SDM COLLEGE NATUROPATHY AND YOGIC SCIENCES AND SDM NATURE CURE HOSPITAL 
 
Primary Sponsor  
Name  Self 
Address  Sri Dharmasthala Manjunatheswara Yoga And Naturecure Hospital, Shanthivana,Dharmasthala,574216 
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 
Aadhithyan P S  Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences  Department Of Research Methodologies And Department Of Acupuncture.
Dakshina Kannada
KARNATAKA 
7349203918

aadhithya10145@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheswara College Of Naturopathy And Yogic Sciences  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 
Intervention  1. Acupuncture 2. Acupuncture And Cervical Ice Massage  Acupuncture On Anti - Hypertensive Points For 20 Minutes , Ice Massage On Neck For 2 Minutes In Supine Position And 2 Minutes In Prone Position With Acupuncture 
Comparator Agent  1. Cervical Ice Massage  1. Cervical Ice Massage Is Given For 2 Minutes In Supine Position And 2 Minutes In Prone Position. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. THE STUDY WILL INVOLVE BOTH MALE AND FEMALE PARTICIPANTS
2. THE RESEARCH WOULD COVER PEOPLE AGED 30 TO 65 WITH NO MAJOR COMPLICATIONS SUCH TUBERCULOSIS OR HEART DISEASES
3. SUBJECTS WITH HYPERTENSION WHO ARE UNDER ANTI-HYPERTENSIVE MEDICATIONS ORALLY 
 
ExclusionCriteria 
Details  1• Subjects under the age of 30 and above the age of 65 will be excluded from the research.
2• The trial will exclude subjects with complications such as chronic renal disease and post-traumatic / surgical recovery.
3• Subjects with cardio vascular disease.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Blood Pressure And Heart Rate Variability  Baseline
After 20 minute of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the effects between 3 groups.  Baseline
20 minutes post intervention
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   10/08/2023 
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="4"
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  

Hypertension is a common, chronic, age-related condition that frequently leads to devastating cardiovascular and renal consequences. Blood pressure is frequently measured in conjunction with other risk factors for cardiovascular disease. Hypertension diagnosis is increasingly reliant on automated blood pressure testing techniques. Contrarily, hypertension has become more common, particularly in LMICs (low- and middle-income countries). According to estimates, 1.39 billion persons worldwide (13.1%) had hypertension in 2010. Adults were more likely to have hypertension in LMICs (31.5%, 1.04 billion individuals) than in high-income nations (28.5%, 349 million people). The pathogenesis of essential hypertension is based on the kidney’s main or secondary inability to eliminate salt at normal blood pressure. The condition is also influenced by the central nervous system, endocrine factors, major arteries, and microcirculation. The sympathetic nervous system and the renin-angiotensin-aldosterone system are two major pathophysiologic processes of Hypertension. Endothelial dysfunction, enhanced vascular reactivity, and vascular remodeling are all symptoms of endothelial dysfunction. If BP cannot be brought to target with lifestyle changes alone, drug treatment is required. Diuretics, ACE inhibitors (angiotensin-converting enzyme inhibitors) or angiotensin receptor blockers (ARBs), beta-blockers, and calcium channel blockers (CCBs) are among the first-line drugs used to treat hypertension. For some people, using two or more antihypertensive drugs is necessary to reach their goal blood pressure. Heart rate variability (HRV) has a well-established role as a measure of cardiovascular risk and offers indirect insight into the tone of the autonomic nervous system. Rapid variations may particularly represent changes in sympathetic and vagal activity, according to the theory behind HRV analysis. In contrast to SDNN and SDANN, which represent both sympathetic and parasympathetic regulation of heart rate, prior research has demonstrated that PNN50 and RMSSD are indicators of parasympathetic activity . Heart rate (HR) is a nonstationary signal; variations in it may convey clues to a sickness that is already present or alerts to oncoming cardiac conditions. The signs can be constant or might appear at random—during specific periods of the day. To analyze and identify anomalies in vast amounts of data gathered over several hours takes effort and time.

Acupuncture is the therapeutic practice of putting one or more needles into particular locations on the body’s surface .The ideas of "meridian" and the life force "Qi" are part of the theoretical underpinnings of needling at particular acupuncture locations in traditional Chinese medicine. According to studies, a needle piercing the skin, whether or not at an acupuncture point, has physiological consequences. There have been theories put out to explain the apparent analgesic effect of acupuncture, including the "gate control theory" and the release of endogenous opioids . Acupuncture has become a popular medical choice both in the West and the East due to its technical simplicity, noninvasiveness, and absence of negative side effects when compared to Western pharmaceutical and surgical treatments .

One of the frequent hydrotherapeutic techniques is ice massage. The current study is the first of its type, and it was done to assess how an ice massage to the neck affected individuals with hypertension’s blood pressure and heart rate variability. Ice application has been demonstrated to cause physiological effects. One of the naturopathic therapies used to lower blood pressure is ice massage (IM) of the head and spine.One of the most significant risk factors for chronic renal disease, ischemic heart disease, stroke, and other cardiovascular diseases (CVDs) is high blood pressure. Systolic blood pressure (SBP) 140     mmHg or diastolic blood pressure (DBP) 90 mmHg are considered elevated  blood pressure.

 
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