| 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
|
|
|
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
|
|
|
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. .
|