FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092342 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Opd prcedure]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Chemical Cautery Plus Medication: Does It Outperform Medication Alone for Allergic Rhinitis? 
Scientific Title of Study   Effectiveness of chemical cautery along with medical therapy versus medical therapy alone in treatment of Allergic rhinitis-a randomized controlled 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  Dr Vedanth M 
Designation  1st year Junior resident 
Affiliation  S Nijalingappa medical College and hospital 
Address  Department of otorhinolaryngology SNMC,Bagalkot
S Nijalingappa medical College Navanagara Bagalkot Karnataka
Bagalkot
KARNATAKA
587102
India 
Phone  8310886986  
Fax    
Email  vedanthveena98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangappa S Doddamani 
Designation  Professor  
Affiliation  S Nijalingappa medical College and hospital 
Address  Department of otorhinolaryngology SNMC,Bagalkot
S Nijalingappa medical College Navanagara Bagalkot Karnataka
Bagalkot
KARNATAKA
587102
India 
Phone  9448960218  
Fax    
Email  sangappadoddamani112@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vedanth M 
Designation  1st year Junior resident 
Affiliation  S Nijalingappa medical College and hospital 
Address  Department of otorhinolaryngology SNMC,Bagalkot
S Nijalingappa medical College Navanagara Bagalkot Karnataka
Bagalkot
KARNATAKA
587102
India 
Phone  8310886986  
Fax    
Email  vedanthveena98@gmail.com  
 
Source of Monetary or Material Support  
Department of otorhinolaryngology SNMC Bagalkot PIN CODE-587102 Karnataka India 
 
Primary Sponsor  
Name  S Nijalingappa medical College and hospitalinstitute Bagalkote 
Address  S Nijalingappa medical College and hospital , Bagalkote , pin-587102, Karnataka , India 
Type of Sponsor  Private medical college 
 
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 Vedanth M   HSK hospital S Nijalingappa medical College   ENT OPD number-7, Department of ENT SNMC ,Bagalkot
Bagalkot
KARNATAKA 
8310886986

vedanthveena98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC institutional ethics committee on human subject trials   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 
Intervention  Chemical cautery of inferior turbinates along with medical therapy   Chemical cautery with local application of 15%silver nitrate which will be done in anterior part of bilateral inferior turbinates and corresponding part of septum after 4%Lognocaine packing ,minimum 2-3 application of 15% silver nitrate at 8 to 12 days apart done, along with medical therapy with tabletlevocetrizine 2.5 mg and phenylephrine 10mg given orally for 3 months Follow up ate every 8 to 12 for 3 months  
Comparator Agent  Medical therapy  medical therapy with yav levocetrizine 2.5 mg and phenylephrine 10mg given orally for 3 months Follow up ate every 8 to 12 for 3 months 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients between 15-75 years with complaints of sneezing,rhinorrhea, headache, nasal block with or without inferior turbinate hypertrophy and patient giving consent for study 
 
ExclusionCriteria 
Details  1.Smokers
2.Pregnant women
3.Patients with age less than 15 years or more than 75 years
4.Anatomic defect of nose like marked Deviation of nasal septum
5.Chronic respiratory illness
6. Nasal polyps
7. Foreign body in nose
8.Adenoid hypertrophy
9.Synechiae
10.Recent nasal surgeries history
11.Nasal mass
12.Patients not giving consent for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement of symptoms lole nasal block excessive sneezing and nasal irritation and long symptom free period after chemical cauterization of bilateral inferior turbinates   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of symptoms within in 15-30 days & long symptom free period for greater than 6 months  6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/08/2025 
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 - NO
Brief Summary   Allergic Rhinitis is common in our country. Symptoms characteristics of allergic rhinitis can occur due to the hyperactivity of nasal mucosa to endogenous or exogenous stimulants8.
Rhinitis is defined as the presence of at least one of the following- nasal congestion, rhinorrhea, sneezing, nasal itching and nasal obstruction. Other reported symptoms include throat clearing, headache ,facial pain, ear pain, itchy throat and palates, ocular symptoms and sleep disturbance. Since allergic rhinitis is induced by specific allergen, it makes sense that avoiding those triggers would be an effective treatment. However this is not always possible.10
Common treatment options include Antihistamines, Decongestants, corticosteroids [topical or systemic], mast cell stabilizers, Immunotherapy or surgical treatment like surface or submucosal cautery, different forms of laser cautery, cryosurgery, turbinectomy. Chemical used for chemical cautery is 15% Silver nitrate which is considered safe by carcinogenic potency database and is widely used on skin or mucosa by various medical specialties.9
In this method we actually cauterize the Trigger area. This area is very sensitive to allergens whose stimulation may lead to attack of allergic rhinitis. This area include anterior part of inferior turbinate and corresponding adjacent part of septum which is the first area to be exposed to allergen on inhalation.1
This study aims at comparing the efficacy of combined treatment with medical therapy and 15 % silver nitrate cauterization against medical therapy alone in the treatment of allergic rhinitis.
INCLUSION CRITERIA:
1. All the patient between age group 15-75years with complaints of sneezing, rhinorrhea, headache, nasal block with or without inferior turbinate hypertrophy
2.Patient giving consent for the study
EXCLUSION CRITERIA:
1.Smokers
2.Pregnant women
3.Patients with age less than 15 years or more than 75 years
4.Anatomic defect of nose like marked Deviation of nasal septum
5.Chronic respiratory illness
6. Nasal polyps
7. Foreign body in nose
8.Adenoid hypertrophy
9.Synechiae
10.Recent nasal surgeries history
11.Nasal mass
12.Patients not giving consent for the study.

METHODOLOGY:
It is a Hospital based Randomized control prospective study on 60 patients clinically diagnosed with allergic rhinitis will be conducted on the patients attending the OPD of Department of ENT, at SNMC and HSK Hospital & RC, Bagalkot after receiving ethical clearance certificate. Detailed history from the selected patients will be taken particularly in relation to duration of disease, previous medications, and extent of relief with previous treatment and complete ENT examination will be done. Diagnostic nasal endoscopy will be done to confirm findings and rule out other causes like nasal block with DNS, nasal polyposis, foreign body, synechiae, mass. Routine investigations will be done . SNOTT 22 Questionnaire will be given to patients and score will be evaluated.
Patients will be divided randomly into two groups based on computer generated randomization table. First group will undergo chemical cautery with 15% silver nitrate which will be done in anterior part of inferior turbinate and corresponding part septum after 4 percent xylocaine nasal packing along with it they will be receiving medical therapy and other group will be receiving only medical therapy 
Patients from both group will be called for follow after 8 to 12 days . chemical cauterization will be repeated in 1st group and SNOTT 22 questionnaire will be given to patients both groups. Results were compared . Patients were followed up for minimum period of 3 months for improvement in symptoms based on SNOTT 22 score. .


 
Close