| CTRI Number |
CTRI/2025/07/091690 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Nasal Sprays and the Brain: Exploring Effects on Smell and Memory |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF OXYMETAZOLINE, XYLOMETAZOLINE,
AND PLACEBO NASAL SPRAYS ON ODOR-SPECIFIC OLFACTORY
PERCEPTION AND COGNITIVE FUNCTION IN HEALTHY ADULTS: A
RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER PILOT
STUDY |
| 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 Charumathi P C |
| Designation |
Postgraduate resident, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
PG room, dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
07339584784 |
| Fax |
|
| Email |
charumathipc2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka S |
| Designation |
Associate Professor, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Associate Professor room, dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Associate professor room, Dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
09844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charumathi P C |
| Designation |
Postgraduate resident, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
PG room, dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
07339584784 |
| Fax |
|
| Email |
charumathipc2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Charumathi P C |
| Address |
PG room, dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070 |
| 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 Charumathi P C |
Kempegowda Institute of Medical Sciences |
Dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
07339584784
charumathipc2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KIMS, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers providing informed consent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oxymetazoline 0.05% (Spray A) |
Oxymetazoline 0.05% Nasal spray-one puff per nostril is administered |
| Comparator Agent |
Placebo-normal saline 0.9% (Spray C) |
Placebo-normal saline 0.9% Nasal spray (one puff per nostril) |
| Intervention |
Xylometazoline 0.1% (Spray B) |
Xylometazoline 0.1% Nasal spray-one puff per nostril |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy human volunteers aged 18–35 years
2. Normosmic (normal sense of smell) |
|
| ExclusionCriteria |
| Details |
1. Nasal disorders, allergies, chronic rhinitis, current smokers
2. Upper respiratory tract infection in the past 4 weeks
3. Neurological or psychiatric disorders
4. Cardiovascular disease or hypertension
5. Current use of decongestants or antihistamines |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in odor identification scores across sprays and timepoints (olfactory test) and Changes in Stroop interference score and memory recall (5 word memory recall test and stroop test) |
0 minute(baseline), +5 minutes. +10 minutes, +30 minutes and +60 minutes followed by 48 hours washout period for each drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in nasal patency (Visual Analogue Scale) and Comparison of onset and duration of effects |
followed by 48 hours washout period for each drug |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 4 |
|
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="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Although oxymetazoline and xylometazoline are widely
used to relieve nasal congestion and improve airflow, the extent to which they
enhance olfactory perception—and whether this translates into cognitive effects—remains
unclear. Furthermore, there is no controlled crossover study comparing
these two decongestants directly on both smell and cognition in healthy adults.
By directly comparing them against placebo and measuring cognitive and
olfactory outcomes at targeted timepoints, this study bridges a vital gap by
systematically evaluating whether standard ENT decongestants not only relieve
nasal congestion but also modulate olfactory-driven neural circuits and thereby
influence cognitive performance in real time. |