| CTRI Number |
CTRI/2024/07/071058 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Horizontal and Broken jet pulmonary douche on Autonomic variables in healthy individuals |
|
Scientific Title of Study
|
The immediate effect of Horizontal and Broken jet pulmonary douche on Autonomic variables in healthy individual -A randomised 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 km Shweta Malik |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India Meerut
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9068421746 |
| Fax |
|
| Email |
shwetamalik735@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 Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram
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 Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Km Shweta Malik,
Maharshi Aurbindo Subharti college hospital naturopathy yogic sciences, swami Vivekananda Subharti university Subhartipuram NH-58 Delhi- Haridwar Bypass road Meerut (UP) India 250005 |
|
|
Primary Sponsor
|
| Name |
Dr km Shweta Malik |
| 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 Financed] |
|
|
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 km Shweta Malik |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekananad Subharti University
Subhartipuram NH-58
Delhi-Haridwar Bypass
Road
Meerut
UTTAR PRADESH |
9068421746
shwetamalik735@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 |
| Healthy Human Volunteers |
autonomic variables |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
broken jet pulmonary douche |
Subject will be in minimum clothing’s. A glass of water should be taken before and after the procedure. pulmonary Douche will be applied on the subjects using broken douche to group. After the treatment the subjects will dry themselves and one glass of water will be given and after 5 min post data will be taken. pulmonary douche will be first applied to the soles of foot then to the arms, shoulder, upper back, and lateral sides of the chest on either side. This procedure contains 10 rounds which will be rotatory. Pressure: 5 to 50 pounds.
Temperature: 92-95° F Applied by means of a nozzle attached to a piece of rubber tubing of 2-3 feet, The jet consists of single stream of water applied with full force. Nozzle with diameter ranging from a millimeter to an inch with a general size of 3/8 to 1/2 inch.Lesser force is applied by breaking the force of stream near the mouth of the nozzle to scatter the column of water to the desired extent.
Total duration: 15 minute |
| Intervention |
horizontal jet pulmonary douche |
Subject will be in minimum clothing’s. A glass of water should be taken before and after the procedure. pulmonary Douche will be applied on the subjects using horizontal douche to group. After the treatment the subjects will dry themselves and one glass of water will be given and after 5 min post data will be taken. pulmonary douche will be first applied to the soles of foot then to the arms, shoulder, upper back, and lateral sides of the chest on either side. This procedure contains 10 rounds which will be rotatory.
Pressure: 5 to 50 pounds.
Temperature: 92-95° F
Applied by means of a nozzle attached to a piece of rubber tubing of 2-3 feet, The jet consists of single stream of water applied with full force.
Nozzle with diameter ranging from a millimeter to an inch with a general size of 3/8 to 1/2 inch.
Total duration: 15 minute
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age between group of 18 to 25 years.
Subjects who are willing to participate in the study.
Both males and females.
|
|
| ExclusionCriteria |
| Details |
Female under menstruation
Pregnant and lactating women.
Subjects with diagnosed medical conditions.
Inflammatory skin conditions.
Recent surgeries.
Subjects having a history of mental disorder.
Substance abuse regularly.
Pyrexia due to any reason.
Cardiovascular co-morbidities.(52)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV (Heart Rate Variability) |
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure (SBP, DBP), Pulse rate, RR |
15 minutes |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2024 |
| Date of Study Completion (India) |
15/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 randomized control study aims to explore the immediate effect of Horizontal and Broken jet pulmonary douche on Autonomic variables in healthy individual.This study will be done to assess the effect of horizontal and broken jet pulmonary douche on autonomic variables in healthy individuals. The intervention of horizontal Pulmonary douche and broken jet Pulmonary douche will be given to the allocated subjects. The evaluations will be taken five minutes before the intervention, followed by a post-assessment five minutes later. The HRV will be recorded with the Power lab 15T while in the supine resting position. Data will be analysed in the temporal or frequency domains. 20% data collection has been done. |