| CTRI Number |
CTRI/2025/12/098286 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of a Nerve Stimulation Therapy and Breathing Techniques in College Students with Asthma |
|
Scientific Title of Study
|
Non-Invasive Vagus Nerve Stimulation Combined with Diaphragmatic Aspiration Technique and Diaphragmatic Scoop Technique: A Comparative Analysis Among College Students with Bronchial Asthma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Kaushik |
| Designation |
Lecturer |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room no 003, Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9025396800 |
| Fax |
|
| Email |
kaukram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room no 003, Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
S Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room no 003, Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute. |
|
|
Primary Sponsor
|
| Name |
R Kaushik |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Poonamalle High Road
Velappanchavadi, Chennai, Tamilnadu - 600077, India |
| 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 R Kaushik |
Faculty of Physiotherapy, A.C.S. Medical College and Hospital |
Faculty of Physiotherapy, A.C.S. Medical College and Hospital Poonamalle High Road (Chennai – Bangalore Highway – NH4) Velappanchavadi - 600077
Chennai
TAMIL NADU |
9025396800
kaukram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S. Medical College Hospital A Constituent Unit of Dr. M.G.R. Educational and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Expiratory Training |
Conventional Expiratory Training - 30 minutes / day for 3 days a week for 12 weeks
|
| Intervention |
Diaphragmatic Aspiration Technique and Diaphragmatic Scoop Technique |
Diaphragmatic Aspiration Technique -30 minutes / day for 3 days a week for 12 weeks
Diaphragmatic Scoop Technique -30 minutes / day for 3 days a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
College Students with clinically diagnosed bronchial asthma
Subjects in the Age Group Range of 18 – 25 years
Both male and female subjects
Mild to moderate Airway obstruction using PEFR with pre and post test reversibility of at least 20%
Mild to moderate Airway obstruction with Fev1 / Fvc Ratio - 60 to 70 percent
Mild to Moderate Asthma as per GINA severity grading
|
|
| ExclusionCriteria |
| Details |
Subjects below the age of 18 and above 25
Subjects with any Active respiratory infection
Subjects with Restrictive Airway Disease like IPF
Subjects with Active Tuberculosis Infection
Subjects with COPD, ACOS, Cystic Fibrosis
Subjects with Congenital and other acquired heart diseases
Subjects with chest wall deformities – Pectus Excavatum and Arcuatum
Pregnant Female subjects
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Inspiratory Capacity and Expiratory Flow
Dyspnea Assessment |
baseline
3 weeks
6 weeks
9 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence of Asthma Exacerbations
Quality of Life Assessment |
baseline
3 weeks
6 weeks
9 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="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 study is designed to investigate and compare the therapeutic effectiveness of non-invasive vagus nerve stimulation combined with diaphragmatic aspiration versus the diaphragmatic scoop technique in mitigating dynamic hyperinflation and managing acute asthma exacerbations among medical college students with clinically diagnosed bronchial asthma. The primary objective is to determine the comparative efficacy of these interventions in optimizing asthma management within this cohort. Furthermore, the study aims to assess the effects of non-invasive vagus nerve stimulation on the control of acute exacerbations and to elucidate its relative benefits over diaphragmatic aspiration and the diaphragmatic scoop technique in reducing dynamic hyperinflation. Primary outcome measures will include comprehensive respiratory function assessments, specifically inspiratory capacity, peak expiratory flow rate, and flow-volume loop analysis, alongside evaluation of dyspnea severity using the Modified Medical Research Council (MMRC) scale. Secondary outcomes will involve assessing the frequency of asthma exacerbation recurrence utilizing the Asthma Control Test (ACT) and Asthma Control Questionnaire (ACQ), as well as determining the impact of interventions on health-related quality of life through the Asthma Quality of Life Questionnaire (AQLQ). |