| CTRI Number |
CTRI/2026/01/100415 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| 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
|
effect of immersion bath and breathing technique for asthma patients |
|
Scientific Title of Study
|
Evaluating the Combined effectiveness of Head out water Immersion and Box breathing on lung function in asthma patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Linghesh R |
| Designation |
UG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences Ujire Belthangady Taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8270188124 |
| Fax |
|
| Email |
linghesh23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Div of Nutrition |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Dept of Nutrition Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences Ujire Belthangady Taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Div of Nutrition |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Dept of Nutrition Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences Ujire Belthangady Taluk Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Nature cure and yoga hospital shantivana
Darmasthala, Belthangady, Dakshina kannada district Karnataka india 574240 |
|
|
Primary Sponsor
|
| Name |
Linghesh R |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy And Yogic Sciences Ujire Belthangady Taluk Dakshina Kannada Karnataka india 574240 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Geetha B Shetty |
SDM Nature cure and Yoga hospital shantivana Darmasthala |
COE, room no 2 Dept of Research, Dharmasthala belthanagady Karnataka India 574240
Dakshina Kannada
KARNATAKA |
9449714767
gbsujire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Dharmasthala Manjunatheshwara College of Naturopathy and yogic sciences Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Box breathing |
Rythemic breathing pattern of inhalation 4sec, hold 4 sec, exhailation 4sec and hold 4 sec |
| Comparator Agent |
Box breathing and head out water immersion |
Evaluating the combined effectiveness of head out water immersion and box breathing on lung function in asthma patients
duration -30minutes |
| Intervention |
Head out Water Immersion |
Subject will be made to lie in a water tub immersing the whole body and head out for 20minutes
Duration- 20minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients carrying a clinical diagnosis of asthma for more than 6 months with mild to moderate symptoms requiring treatment asthma symptoms at least twice per week and a maximum 5 times per week |
|
| ExclusionCriteria |
| Details |
1 Participating in another clinical trial
2 co morbidity with other lung or systemic disease
3 past bleeding or coagulopathy
4 use of antidepressant medication
5 pregnancy
6 smoker or ex-smoker who quit less than 1 year ago or drug addict |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PFT
1 FVC
2 FEV1
3 FEV1/FVC |
pre
post (immediately 5min after the intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in peak expiratory flow rate from baseline |
Baseline end of intervention and follow up |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This research study aims to evaluate the combined effect of head-out water immersion and Box Breathing on lung function in patients with Bronchial Asthma The project will measure how the unique physiological effects of water immersion which increases pressure on the chest and shifts blood volume work in conjunction with the controlled rhythmic breathing pattern of the Box Breathing technique to improve respiratory parameters primarily Forced Expiratory Volume in 1 second The goal is to determine if this combined non-pharmacological intervention can lead to clinically significant improvements in lung function asthma control and quality of life for asthma patients compared to a control group |