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CTRI Number  CTRI/2024/04/066231 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see the effectiveness of posterior nasal neurectomy in patient with persistent allergic rhinitis along with medical management. 
Scientific Title of Study   A randomized controlled trial to evaluate the efficacy of posterior nasal neurectomy as treatment modality in patient with persistent allergic rhinitis along with medical management. 
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 Shuchita Singh Pachaury 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4053A

South
DELHI
110029
India 
Phone  9868398897  
Fax    
Email  drshuch@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shuchita Singh Pachaury 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4053A

South
DELHI
110049
India 
Phone  9868398897  
Fax    
Email  drshuch@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shuchita Singh Pachaury 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4053A

South
DELHI
110049
India 
Phone  9868398897  
Fax    
Email  drshuch@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  AIIMS, Ansari Nagar, New Delhi - 110029 
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 Basant Kunwar  All India Institute of Medical Sciences  Department of Otorhinolaryngology, D4 ward, Ansari Nagar, New Delhi
South
DELHI 		 7701877437

drbasantkunwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  These patient will be receiving medical therapy (Fluticasone nasal spray 2 puff and Tablet Levocetrizine 5mg HS + reduce allergen exposure + Alkaline Nasal Douching QID) according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines 
Intervention  Posterior Nasal Neurectomy + Medical Management  Posterior Nasal Neurectomy will be performed with the subjects either on LA or GA on both nostril and they will also receive medical therapy (Fluticasone nasal spray 2 puff and Tablet Levocetrizine 5mg HS + reduce allergen exposure + Alkaline Nasal Douching QID) according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Valid informed consent to be enrolled in the study
Either Gender of age 16 to 65 years
Persistent Allergic Rhinitis diagnosed on basis of ARIA guideline
 
 
ExclusionCriteria 
Details  Having complications of nasal disease, polyp or mass
Having complications of bacterial or viral infection of URTI
Pregnant woman and lactating mothers
History of hypersensitivity to steroids
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see efficacy of posterior nasal neurectomy using
SNOT 22 score
TNSS score
Rhinomanometry
 		 Pre intervention
3 months post intervention
6 months post intervention

 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following stress markers in patient undergoing intervention
Perceived Stress Scale
Voice Based Analysis
Serum Cortisol Analysis 		 Pre intervention
3 months post intervention
6 months post intervention 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   05/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [DRBASANTKUNWAR@GMAIL.COM].

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This research is intended to find out the Efficacy of Posterior Nasal Neurectomy as treatment modality in patients with Persistent allergic rhinitis (PAR) along with medical management. It may help us in future to set a fixed protocol which can be applied universally on all patients so that the modality of treatment does not remain subjective for a particular individual. The society at large will be benefitted as there is not much evidence regarding what exactly to give the treatment. 
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