| 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
|
|
|
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
|
|
|
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. |