FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078194 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Breathing techniques for runny nose 
Scientific Title of Study   Effectiveness of nasal rehabilitation on nasal symptoms in patients with chronic allergic rhinitis: A randomized 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  Sachin Tendulkar 
Designation  PG student 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9611607898  
Fax    
Email  sachinsapps2710@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V Prem 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr V Prem 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore


KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road,Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prem V  Manipal Hospitals Bangalore  No.98, Rustam Bagh Road, Old Airport Road,Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017
Bangalore
KARNATAKA 
9886647732

prem.v@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J310||Chronic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasal rehabilitation  Nasal breathing exercises include breath holding technique, unilateral and bilateral humming and nose open smile. All the techniques for five repetitions twice a day for five weeks. 
Comparator Agent  Patient education  Patient education and counselling for prevention of exposure to allergens by using masks. Avoiding intake of cold beverages. Encouraging adherence to medicine and use of nasal spray. Explanation of causes for allergic rhinitis and its complications. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients diagnosed with chronic allergic rhinitis by pulmonologist 
 
ExclusionCriteria 
Details  Severe seasonal allergic rhinitis, craniofascial disorder, tracheostomy dependence, prior history of laryngeal, subglottic or pulmonary airway stenosis or surgery, severe psychological problems, other lower respiratory tract disorders, smokers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Total nasal symptoms score  Baseline and every week for five weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nasal obstruction symptom evaluation score  Baseline and after five weeks 
Rhinoconjunctivitis quality of life questionnaire  Baseline and after five weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 1 
Date of First Enrollment (India)   25/12/2024 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Allergic rhinitis and its impact on asthma [ARIA] define Allergic Rhinitis [AR]as“Type 1 hypersensitive inflammation of the nasal mucosa Induced by exposure to allergic substance.  With at least two or four cardinal nasal symptoms namely sneezing, rhinorrhoea, nasal itching and nasal block present>1 hour/day on most/many days in a year”[1]. The global prevalence of AR is found to be 5% to 50% . In India the prevalence is said to be approximately 22% in adolescents[3].
The early response to the exposure to the allergens causes sneezing, rhinorrhoea, inflammation of mucosal glands and nasal congestion which is mediated by the IgE and lasts for 5 to 15 minutes[4]. The late response which lasts for 4 to 6 hours can causes nasal mucosa production, nasal edema and nasal congestion, which is leukotriene mediated[5].   Based on the symptoms AR can be subdivided  as intermittent [acute] and persistent [chronic]. The AR is said to be acute, If the symptoms of AR are seen for less than 4 weeks or less than 4 days per week and lasting more than that is termed as chronic AR[1][4].  the symptoms of the chronic AR  is same as acute rhinitis but,  the mouth breathing pattern , blueish discoloration of lower eyelids[allergic shiners] seen in the patients with the chronic AR[6] .Mouth breathing can cause reduction in oral hydration, mucociliary clearance, local innate immune defence and mucosal homeostasis due to the lack of oscillatory mechanical pressure that happens in nasal breathing [7][8].There will be reduction in intraoral space which can cause obstruct the pharyngeal airway , nasal muscle dysfunction in mouth breathing[9] .Numerous studies have proven the adverse effect of mouth breathing[10][11][12] . Additionally, some research suggests that improving oral breathing problems does not always result from orthodontic treatment that enlarges the nasal cavity[9] .
The diagnosis of the AR is done by skin prick testing, rhinoscopy and allergic specific IgE test[2].  Pharmacological treatment in AR includes intranasal corticosteroids, antihistamines decongestants, leukotriene receptor antagonists and immunotherapy. All these drugs have several side effects and also increase dependency on drugs[3]. Surgical approach in the AR include inferior turbinate reduction, lateralization outfracture, laser vaporization, radiofrequency abalation and cobalation, sub mucosal resection, septoplasty and endoscopic sinus surgery[14]. Non pharmacological approach include nasal rehabilitation, which could be an alternative measure. There is lack of literature in  the study to evaluate both mouth breathing and nasal symptoms in patients with chronic allergic rhinitis existing literature lack assessment of mouth breathing in patients with chronic allergic rhinitis.
 
Close