| CTRI Number |
CTRI/2025/12/099635 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two nerve based procedures for treating moderate to severe persistent allergic Rhinitis |
|
Scientific Title of Study
|
Comparison of outcomes of posterior nasal neurectomy with radiofrequency ablation versus bipolar diathermy in patients with intractable moderate to severe persistent allergic rhinitis – An Academic 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 |
Aakash Reddy Gade |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All india institute of medical sciences, mangalagiri |
| Address |
Department of ent, room 311, aiims mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9603079161 |
| Fax |
|
| Email |
aakashreddygade77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seepana Ramesh |
| Designation |
Associate Professor |
| Affiliation |
All india institute of medical sciences, mangalagiri |
| Address |
Department of ent, room 311, aiims mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9490713477 |
| Fax |
|
| Email |
ramesh.s@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aakash Reddy Gade |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All india institute of medical sciences, mangalagiri |
| Address |
Department of ent, room 311, aiims mangalagiri
ANDHRA PRADESH
522503
India |
| Phone |
9603079161 |
| Fax |
|
| Email |
aakashreddygade77@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aakash Reddy Gade |
| Address |
Department of ent, room 311, aiims mangalagiri, guntur, andhra pradesh, india
pincode:522503 |
| Type of Sponsor |
Government 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 |
| Aakash Reddy Gade |
AIIMS Mangalagiri |
ROOM 311 3RD FLOOR ENT OPD AIIMS MANGALAGIRI GUNTUR AP 522503
Guntur
ANDHRA PRADESH |
9603079161
aakashreddygade77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITE ETHICS COMMITTEE AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bipolar ablation of posterior nasal nerve |
Bipolar ablation of the posterior nasal nerve is a minimally invasive procedure done to treat severe allergic rhinitis (persistent sneezing, runny nose, and nasal blockage) when medicines do not give enough relief.
Inside the nose, there is a small nerve called the posterior nasal nerve that causes excessive nasal secretions and irritation. In this procedure, this nerve is gently treated using controlled electrical energy to reduce its activity. This helps decrease symptoms like a runny nose, sneezing, and nasal congestion.
The procedure is performed through the nose using an endoscope.
A special bipolar probe is used to deliver controlled energy to the nerve.
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
radiofrequency ablation of posterior nasal nerve |
Radiofrequency ablation of the posterior nasal nerve is a minimally invasive treatment used for patients with severe, long-standing allergic rhinitis (frequent sneezing, runny nose, and nasal blockage) that does not improve with medicines
Inside the nose, there is a small nerve called the posterior nasal nerve that contributes to excessive nasal secretions and irritation. In this procedure, controlled radiofrequency energy is used to reduce the activity of this nerve, helping to relieve nasal symptoms
The procedure is performed through the nostrils using a small endoscope
A thin radiofrequency probe is placed near the nerve and gentle energy is delivered |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Persistent moderate to severe allergic rhinitis
2. 18-60 years males and females
3. No improvement in symptoms with 3 months usage of intranasal steroid spray
|
|
| ExclusionCriteria |
| Details |
1. Patients with gross deviated nasal septum
2. Patients with nasal polyps
3. Patients with acute rhinosinusitis
4. Patients with previous history of nose surgeries
5. Patients with previous history of radiation exposure to head and neck
6. Pregnant Women
7. Patients using oral contraceptive pills, antipsychotics
8. Patients with hypothyroidism
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SNOT22 questionnaire (sinonasal outcome test) |
Preoperatively,
1 month,
3 months,
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare duration of surgery, intraoperative bleeding between two groups
• To compare postoperative crusting using diagnostic nasal endoscopy between two groups
• To assess quality of life before & after the procedures between the two groups using RQLQ (Rhinoconjunctivitis quality of life questionnaire)
• To compare outcome of nasal symptoms after posterior nasal neurectomy between the two groups using VAS (visual analog scale)
|
Preoperatively,
1 month,
3 months,
6 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hypothesis
Posterior
nasal nerve neurectomy with radiofrequency ablation is equally efficacious as
bipolar diathermy in alleviating symptoms in patients with intractable allergic
rhinitis
The
different modalities of treatment for allergic rhinitis
include avoidance of causative
allergen, interventions in the form of intranasal steroid spray and other
pharmacological interventions, immunotherapy, surgical modalities. Medical management is effective in allergic
rhinitis but require prolonged treatment with side effects
A subset of patients are however refractory to medical
management
Immunotherapy can cause substantial financial burden as
it is given for prolonged time.
Surgical
treatment is indicated for patients who have
inadequate response to medical management
Vidian
neurectomy historically was done for refractory rhinitis and several studies
revealed it is effective in reducing symptoms, but can cause side effects like
dry eyes, numbness of cheeks and palate, abducens palsy, eye muscle disorders,
postoperative hemorrhage
Modalities
that target postganglionic posterior nasal nerve branches of vidian nerve helps
reduce side effects associated with vidian neurectomy.
Different
tools that can be used are radiofrequency ablation, cryoablation, bipolar
diathermy, laser ablation of posterior nasal nerve
Temperature
controlled radiofrequency ablation involves monitoring tissue temperature and
adjusts radiofrequency current reducing excess damage to the tissue
In
this study the comparison is done for outcomes of posterior nasal nerve
neurectomy with radiofrequency ablation versus bipolar diathermy in patients
with intractable moderate to severe persistent allergic rhinitis on which
limited studies are present |