| 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
|
|
|
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
|
|
|
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 yearâ€[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. |