| CTRI Number |
CTRI/2026/02/104313 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to Develop and Evaluate a New Combination Ear Drop for Reducing Pain and Inflammation in Patients with Inflammatory Ear Disorders |
|
Scientific Title of Study
|
Development of a Novel ear drop formulation OTICRELIEF HC containing Hydrocortisone and Lignocaine for Inflammatory ear conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHURANI RITU |
| Designation |
PG student |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of ENT
Saveetha medical college and hospitals
Saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9677345906 |
| Fax |
|
| Email |
ritunagarajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shankar Ganesh |
| Designation |
Assistant Professsor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of ENT
Saveetha medical college and hospitals
Saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
shankarganesh2908@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHURANI RITU |
| Designation |
PG student |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of ENT
Saveetha medical college and hospitals
Saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9677345906 |
| Fax |
|
| Email |
ritunagarajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospitals
Saveetha Nagar
Thandalam
Chennai
TamilNadu
India
PIN CODE 602105 |
|
|
Primary Sponsor
|
| Name |
BHURANI RITU N |
| Address |
Saveetha Medical College and Hospitals
Saveetha Nagar
Thandalam
Chennai
TamilNadu
India
PINCODE 602105 |
| 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 |
| Bhurani Ritu |
Saveetha Medical college and hospitals |
Department of ENT
Saveetha medical college and hospitals
Saveetha Nagar
Thandalam
Chennai - 602105
Chennai
TAMIL NADU |
9677345906
ritunagarajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H605||Acute noninfective otitis externa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OTICRELIEF HC ear drops |
OTICRELIEF HC ear drops containing hydrocortisone (1% w/v) and lignocaine (2% w/v) will be administered as 2 drops into the affected ear via the topical (aural) route, three times daily, for a total duration of 5 days. |
| Comparator Agent |
Placebo ear drops |
Placebo ear drops identical in appearance to the investigational product, containing only the vehicle without active ingredients, will be administered as 2 drops into the affected ear via the topical (aural) route, three times daily, for a total duration of 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–65 years diagnosed with inflammatory ear conditions were recruited. (e.g., otitis externa without bacterial involvement, post-traumatic inflammation).
No history of allergic reactions to hydrocortisone, lignocaine, or similar compounds.
Patients willing to provide informed consent (or guardian consent for minors).
|
|
| ExclusionCriteria |
| Details |
Chronic ear diseases
Perforated tympanic membrane
Known hypersensitivity to lignocaine or hydrocortisone
Concurrent use of other ear medications that could confound the results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A stable, Ph-balanced, and biocompatible ear drop formulation combining hydrocortisone and lignocaine provides rapid pain relief within minutes of application and reduces inflammation, swelling & itching within few days thus providing improved patient-reported outcomes (VAS pain scores, symptom resolution time).
It will be a non-antibiotic alternative for mild-to-moderate otitis externa with comparable or superior efficacy to existing commercial formulations. |
Day 0 (Baseline): Pre-treatment assessment of symptoms and clinical findings.
Day 0 (30 minutes after first application): Assessment of immediate analgesic effect.
Day 5: Assessment of reduction in inflammatory signs and symptoms and evaluation of overall clinical improvement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in VAS score at Day 3 & Day 7
2.Reduction in external auditory canal edema at Day 7
3.Resolution of otorrhea by Day 7
4.Time in days of complete resolution of symptom
5.Incidents of adverse events during 7-day follow up |
Day 7: Assessment of complete symptom resolution, external auditory canal edema, & recording of any adverse events. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="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
|
Otitis externa (OE) is an inflammatory condition of the external auditory canal, often presenting with pain, itching, and swelling. While it may be infective (bacterial or fungal), several non-infective causes include swimmer’s ear, eczematous dermatitis (ex atopic or seborrheic), neurodermatitis, trauma from cotton bud use, and radiation-induced inflammation. While antibiotic-steroid combination ear drops are being commonly prescribed for otitis externa, many cases of non-infective OE do not require anti-microbial therapy. Thus in non-infective OE, anti-inflammatory and analgesic therapy is often more appropriate. Hydrocortisone, a corticosteroid, effectively reduces inflammation, itching, and swelling, while Lignocaine, a local anesthetic, provides prompt pain relief. Hydrocortisone and lignocaine combination drops are well-tolerated with minimal side effects when used appropriately and are less likely to cause allergic reactions. Hence, developing a novel ear drop combining hydrocortisone and lignocaine (OTICRELIEF HC) offers a targeted, safer, and patient-friendly alternative to conventional antibiotic-steroid ear drops. It provides symptom relief while addressing the growing need for rational antibiotic use in otology avoiding resistance and preserving the normal ear flora. This study is a prospective, randomized, controlled clinical trial designed to evaluate the efficacy and safety of a combination otic solution containing Hydrocortisone and Lignocaine (OTICRELIEF HC) in patients with non-inflammatory otitis externa. A total of 50 participants will be randomized in a 1:1 ratio to receive either OTICRELIEF HC or control treatment. The outcomes are assessed by reduction in ear pain severity measured using the Visual Analog Scale (VAS), resolution of external auditory canal edema and otorrhea by clinical otoscopic examination, requirement of rescue analgesics, and incidence of adverse events. Participants will be followed up for a total period of 7 days (Follow-up logs are maintained for Day 0, Day 3-5, Day 7) to assess clinical response and safety. |