| CTRI Number |
CTRI/2024/05/067051 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Research to find the effect of a neutral circular jet on the HRV values in patients with high blood pressure |
|
Scientific Title of Study
|
Immediate effect of neutral circular jet on autonomic variables among hypertensive patients: a randomized controlled 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 Vipin Pant |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9719859913 |
| Fax |
|
| Email |
vipinpant29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram 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 Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shivaji Subharti Hospital, Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences (IPD, OPD), Subharti University, Meerut-250005 |
|
|
Primary Sponsor
|
| Name |
Dr Vipin Pant |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road Uttar Pradesh
250005 |
| 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 Vipin Pant |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences
Swami Vivekanand Subharti University Subhartipuram NH-58
Delhi-Haridwar Bypass Road Meerut-250005
UTTAR PRADESH
Meerut
UTTAR PRADESH |
9719859913
vipinpant29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti university |
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 circular jet (intervention group) |
Pre-operative: The subjects should drink 1-2 glasses of water before and after the procedure.
Operative: The subject should stand under the running neutral water coming out from the jets
Time Duration: 20 min.
Temperature: 92-95° F
|
| Comparator Agent |
Sham treatment (control group) |
Pre-operative: The subjects should drink 1-2 glasses of water before and after the procedure
Operative: The subject should stand under the circular jet
Time Duration: 20 min
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
Age range of 30–60 years
Primary hypertension
On regular medication
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Participants with a history of secondary hypertension
Hypertensive complications
Coronary heart disease
Stroke
Mental illness
Female having menstruation
Pregnancy
Pyrexia
Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome: HRV (Heart Rate Variability)
a) Frequency domain (LF, HF, LH/HF)
I. The low-frequency band (LF)
II. High Frequency (HF) band
III. The LF/HF ratio will be calculated
b) Time domain (R-R interval, RMSSD, NN50, pNN50)
I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate)
II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals)
III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms)
IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals) |
Primary Outcome: HRV (Heart Rate Variability)
a) Frequency domain (LF, HF, LH/HF)
I. The low-frequency band (LF)
II. High Frequency (HF) band
III. The LF/HF ratio will be calculated
b) Time domain (R-R interval, RMSSD, NN50, pNN50)
I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate)
II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals)
III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms)
IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure (SBP and DBP) Pulse rate Respiratory rate Spo2 |
The evaluations will be taken five minutes before the intervention, followed by a post-assessment five minutes later and the data will be assessed |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
02/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| 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
|
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)
|
A study of a neutral circular jet given with a temperature of 92–95 degrees Fahrenheit for 15 minutes to find its effect upon the autonomic variables of patients with primary (essential) hypertension
20% completed 100% completed |