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CTRI Number  CTRI/2024/07/071702 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [therapeutic]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised control study to analyse the effectiveness of antifungal and steroid nasal douching in allergic fungal rhinosinusinitis 
Scientific Title of Study   A randomised control trial on the effectiveness of antifungal and steroid nasal douching in allergic fungal rhinosinusinitis a clinical, radiological and biochemical corelation 
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 Sowparnika T R 
Designation  Junior Resident 
Affiliation  Aiims New Delhi 
Address  Department of otorhinolaryngology and head and neck surgery Aiims New Delhi

New Delhi
DELHI
110029
India 
Phone  7012608259  
Fax    
Email  sowbutr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hitesh Verma 
Designation  Associate Professor 
Affiliation  Aiims New Delhi 
Address  Department of otorhinolaryngology and head and neck surgery Aiims New Delhi

New Delhi
DELHI
110029
India 
Phone  9868397480  
Fax    
Email  drhitesh10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hitesh Verma 
Designation  Associate Professor 
Affiliation  Aiims New Delhi 
Address  Department of otorhinolaryngology and head and neck surgery, Aiims New Delhi

New Delhi
DELHI
110029
India 
Phone  9868397480  
Fax    
Email  drhitesh10@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, AIIMS New Delhi, Ansari Nagar, New Delhi, 110029 ANSARI NAGAR, NEW DELHI, 110029  
 
Primary Sponsor  
Name  Aiims New Delhi 
Address  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 Sowparnika T R  All India institiute of medical sciences AIIMS New Delhi  Department of otorhinolaryngology and head and neck surgery, 4 th floor, Teaching Block, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI 		 7012608259

sowbutr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Budesonide douching, Tab Prednisolone, Tab Itraconazole  Tablet prednisolone per orally 1 mg/kg/day for 7 days, 0.8 mg/kg for 7 days, 0.6 mg/kg for 7 days, 0.4 mg/kg for 7 days followed by 0.2 mg/kg for 14 days. Tablet Itraconazole 400mg P BD on day 1 followed by 200 mg/day per orally for 6 weeks. Budesonide nasal douching ( 1mg dose of budesonide suspension in 240 ml normal saline – 60 ml of this solution in each nostril BD for 6 weeks)  
Comparator Agent  Tab prednisolone, Tab Itraconazole  Tablet prednisolone perorally 1 mg/kg/day for 7 days, 0.8 mg/kg for 7 days, 0.6 mg/kg for 7 days, 0.4 mg/kg for 7 days followed by 0.2 mg/kg for 14 days. (Total duration 6 weeks). Tablet Itraconazole 400mg PO BD on day 1 followed by 200 mg/day perorally for 6 weeks. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Willing to participate in the study
Above 14 years of age
 
 
ExclusionCriteria 
Details  Patients not tolerating treatment
Complicated afrs
Uncontrolled chronic systemic illness(anticipating toxicity of steroid and itraconazole)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pre and post treatment clinical(SNOT 22 and Meltzer endoscopic scores) and radiological (Lund Mackay and 20 point score) comparison in afrs.  Baseline and at 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pre & post treatment serological (total serum IgE levels
specific IgE levels
Absolute eosinophil counts
serum Interleukin 5 levels
serum galactomannan
nasal douches galactomannan) comparison in afrs
 		 Baseline & at 6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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 - NO
Brief Summary  

Proven studies showing effectiveness of combined approach medical management with systemic steroid, systemic antifungal and steroid nasal douching in pre-surgical patients are not present till date. This study aims to find out the efficacy of antifungal  and steroid nasal douching in AFRS patients presurgically. It also aims to correlate the effectiveness of this therapy with clinico-radiological and biochemical parameters. No randomized control trials are also not available on this aspect. In this study, Tab prednisolone 1 mg/kg for 7 days, 0.8 mg/kg for 7 days, 0.6 mg/kg for 7 days, 0.4 mg/kg for 7 days followed by 0.2 mg/kg for 14 days given (total duration 6 weeks). Patient monitored every 2 weekly with body weight/lft to see adverse effect of steroid therapy and serum cortisol levels on day 7 and 21. Itraconazole 400mg PO BD on day 1 followed by 200 mg/day for 6 weeks  will be given. Pre therapy Liver function test (LFT) will be done and every 2 weekly LFT will be repeated during Itraconazole treatment course. The treatment will be hold in patients with deranged liver function test till the value become normalised. Budesonide nasal douching ( 1mg dose of budesonide suspension in 240 ml normal saline – 60 ml of this solution in each nostril BD for 6 weeks). After 6weeks of therapy, clinical evaluation will be done on the basis of SNOT22 scoring system. Endoscopic evaluation will be done with Meltzer Clinical scoring system. This endoscopic evaluations will be done at 6th weeks from starting of the treatment. All the clinical, biochemical, and radiological parameter will be repeated and compared. Blood samples will be sent for serum total IgE, baseline Aspergillus specific IgE to the Department of Pulmonary Medicine in serum vial.Serum interleukin 5 levels will be measured pre and post treatment. For radiological study, LundMackay system and 20points scoring system CT Scan will be used.Clinical, biochemical parameter will be quantified and compared and radiological parameter pre and post therapy will be compared at 6 weeks to assess the effectiveness of therapy. The patients will be kept on follow-up till 3 months and persistence of disease after 3 months will be considered for surgery.

 
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