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CTRI Number  CTRI/2022/02/040478 [Registered on: 21/02/2022] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Atrophic Rhinitis new treatment 
Scientific Title of Study   Effect of NasoBiome on Nasal microbiome profile of patients suffering from Atrophic Rhinitis- A Randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAURAV SARKAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room 201, Administrative Block Department of ENT and HNS All India Institute of Medical Sciences, Bhubaneswar Sijua Patrapada Bhubaneswar Odisha 751019 Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  09830315933  
Fax    
Email  doc.sauravsarkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SAURAV SARKAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No: 201; Administrative block Department of ENT and HNS All India Institute of Medical Sciences, Bhubaneswar Sijua Patrapada Bhubaneswar Odisha 751019 Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  09830315933  
Fax    
Email  doc.sauravsarkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAURAV SARKAR 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No: 201; Administrative Block Department of ENT and HNS All India Institute of Medical Sciences, Bhubaneswar Sijua Patrapada Bhubaneswar Odisha 751019 Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  09830315933  
Fax    
Email  doc.sauravsarkar@gmail.com  
 
Source of Monetary or Material Support  
Department of Science and Technology Government of Odisha Bhubaneswar Odisha India 
 
Primary Sponsor  
Name  Department of Science and Technology Government of Odisha 
Address  Bhubaneswar Odisha India 
Type of Sponsor  Government funding agency 
 
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 
Saurav Sarkar  All India Institute of Medical Sciences Bhubaneswar  Department of ENT & HNS AIIMS Bhubaneswar Sijua Patrapada Bhubaneswar Khordha ORISSA
Khordha
ORISSA 
9830315933

doc.sauravsarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cases with Nasobiome nasal spray  Duration of intervention 3 months Total duration of study 3 years Controls would get Normal Saline nasal spray Followed up after the period of intervention. 
Comparator Agent  Normal saline  Duration of intervention 3 months Total duration of study 3 years Controls would get Normal Saline nasal spray Followed up after the period of intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults (more than 18 years);
Atrophic Rhinitis based on clinical examination2. 
 
ExclusionCriteria 
Details  Pregnancy, comorbidities that preclude travel for follow up, declining to be included in the study, a SNOT22 score of less than 10. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the improvement in clinical features following intervention using endoscopy score.
To assess the change in nasal microbiome following intervention 
3 years 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the improvement in clinical features following intervention using endoscopy score.
To assess the change in nasal microbiome following intervention 
3 Years 
 
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   N/A 
Date of First Enrollment (India)   01/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Atrophic rhinitis is a chronic, gradually progressing degenerative condition of the nasal cavity characterized by a foul odor (ozena), nasal obstruction, dryness, and crusting. The etiology of primary atrophic rhinitis is mostly unknown. Progressive metaplasia and atrophy of all mucosal components (epithelium, vessels, and glands) takes place because of increased osteoclastic activity, resulting in a volumetric decrease of sinonasal structures. The turbinate show shrinkage and the inferior turbinate is affected the most. Endoscopic inspection reveals a large, wide nasal cavity with dried mucosa. Classically, the management of patients with primary atrophic rhinitis is aimed at alleviating symptoms using nasal irrigation douche or ointment application. In 1971, Young et al proposed closure of the nostril (Young’s operation), and Saunders et al suggested endonasal microplasty (intranasal implant insertion) for the surgical management of primary atrophic rhinitis. However, Young’s operation has its demerit on the possibility of decreased patient’s quality of life.
This study hypothesises that NasoBiome spray will be able to modulate the nasal microbiome of profile of patients with Atrophic Rhinitis thereby curing the disease condition.
This is a RCT where the cases will be treated with the NasoBiome solution nasal spray and the controls will be treated with Normal saline nasal spray for a duration of 3 months after which they will be checked on several parameters like the clinical improvement, histopathological improvement, radiological improvement and microbiome profile change.
 
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