| 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
|
|
|
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
|
|
|
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. |