| CTRI Number |
CTRI/2025/07/091991 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Determination of the quality of life following nasal nerve surgery in patients of Allergic Rhinitis not responsive to medical treatment |
|
Scientific Title of Study
|
Determination of the impact of Posterior Nasal Nerve Neurectomy in patients of Allergic Rhinitis intractable to medical management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Madhavarapu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Oto-Rhino-Laryngology, Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9866273737 |
| Fax |
|
| Email |
sneha.madhavarapu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailesh Pujary |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Oto-Rhino-Laryngology, Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
kailesh.pujary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Madhavarapu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Oto-Rhino-Laryngology, Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9866273737 |
| Fax |
|
| Email |
sneha.madhavarapu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Kasturba Hospital, MAHE, Karnataka, Manipal, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Madhavarapu |
| Address |
Department of Otorhinolaryngology, Kasturba Medical College, Kasturba Hospital, MAHE, Manipal, Karnataka, India - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sneha Madhavarapu |
Kasturba Medical College, Kasturba Hospital, MAHE, Manipal |
Department of Oto-Rhino-Laryngology, Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA |
09866273737
sneha.madhavarapu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
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 |
| Comparator Agent |
Patients undergoing inferior turbinoplasty |
Patients who meet the inclusion criteria undergoing inferior turbinoplasty. Patients who meet the inclusion criteria undergoing inferior turbinoplasty. This is a single-stage surgical procedure performed during one operative session. Postoperative follow-up will be conducted at 1 week, 1 month and 3 month intervals post operatively. Total follow up duration will be of 3 months. |
| Intervention |
Patients undergoing Posterior Nasal Nerve Neurectomy with Inferior Turbinoplasty |
Patients who meet the inclusion criteria undergoing posterior nasal nerve neurectomy with inferior turbinoplasty. Patients who meet the inclusion criteria undergoing posterior nasal nerve neurectomy with inferior turbinoplasty. This is a single-stage surgical procedure performed during one operative session. Postoperative follow-up will be conducted at 1 week, 1 month and 3 month intervals post operatively. Total follow up duration will be of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. AGE – 18 to 50 years of age
2. Gender : Male and Female
3. Cases of Allergic Rhinitis: Patients with moderate/severe Persistent Allergic Rhinitis as per ARIA guidelines (symptoms for more than 4 days per week AND for more than 4 consecutive weeks per year; with one or more of the following : abnormal sleep, impairment of daily activities, sport, leisure, Problems caused at school or work, Troublesome symptoms) having 2 or more typical symptoms of Allergic Rhinitis - anterior or posterior rhinorrhoea, sneezing, nasal blockage and/or itching of the nose – who have shown no significant improvement in symptoms after Medical Management ( with Oral Antihistamines and Steroid Nasal Sprays for more than or equal to 1 month)
4. Allergic Skin Prick Test – Patient sensitized to 1 or more allergens.
5. Associated Anatomical variations such as Septal Deviation, Hypertrophied Turbinates.
6. Bronchial Asthma in addition to Allergic Rhinitis
|
|
| ExclusionCriteria |
| Details |
1. Congenital Anomalies of the nose
2. Patients post Sinonasal surgeries.
3. Sinonasal polyposis
4. Sinonasal malignancies
5. Previous radiation to Head and Neck
6. Head and neck trauma
7. Associated Syndromic conditions such as Kartagener’s syndrome, Young syndrome.
8. Bleeding Diathesis
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life of patients of Allergic Rhinitis intractable to medical management, post Posterior nasal nerve neurectomy by pre operative and post operative comparison of the SNOT 22 score and Total nasal symptom score |
1 week, 1 month and 3 months post Posterior Nasal Nerve Neurectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparing the effectiveness of Posterior Nasal Neurectomy and Inferior Turbinoplasty and a combination of the two procedures (with or without septal correction) in reduction of symptoms of Allergic Rhinitis.
2. Assessment of the effect of Posterior Nasal Neurectomy on the specific symptoms of Allergic Rhinitis.
|
1 week, 1 month and 3 months post Posterior Nasal Nerve Neurectomy |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
09/08/2025 |
| 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="3"
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
|
Assessment of the impact on Posterior Nasal Nerve Neurectomy in patients
of Allergic Rhinitis intractable to medical management of > 1 month by
comparing preoperative and post operative symptom scores and to assess the impact of the surgery on improving the quality of life of patients of Allergic Rhinitis. The study will assess the effect of Posterior Nasal Nerve Neurectomy on specific symptoms of Allergic Rhintis as well and compare the improvement in symptoms with improvement after other procedures such as Inferior Turbinoplasty with or without septal correction.
|