| CTRI Number |
CTRI/2025/04/084435 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In children with allergic cold and cough bilastine drug is compared with levocetirizine drug. |
|
Scientific Title of Study
|
Effectiveness of bilastine versus Levocetirizine in children with allergic rhinitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoshna Nidamanuri |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Pediatrics
AIIMS Mangalagiri
Guntur district
Andhra Pradesh
Department of pediatrics
AIIMS Mangalagiri
Guntur district
Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
08555050666 |
| Fax |
|
| Email |
jyoshnadr123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoshna Nidamanuri |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Pediatrics
AIIMS Mangalagiri
Guntur district
Andhra Pradesh
Department of Pediatrics
AIIMS Mangalagiri
Guntur district
Andhra Pradesh
Krishna
ANDHRA PRADESH
522503
India |
| Phone |
08555050666 |
| Fax |
|
| Email |
jyoshnadr123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diptirekha satapathy |
| Designation |
Asisstant professor |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Department of Pediatrics
AIIMS Mangalagiri
Guntur district
Andhra Pradesh
Department of Pediatrics
AIIMS Mangalagiri
Guntur district
Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
08518887314 |
| Fax |
|
| Email |
diptirekha.satapathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoshna Nidamanuri, Junior resident, AIIMS MANGALAGIRI |
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
ongole, andhrapradesh |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Jyoshna Nidamanuri |
AIIMS MANGALAGIRI |
Room no 321,3rd floor, department of pediatrics, AIIMS MANGALAGIRI
Guntur
ANDHRA PRADESH |
8555050666
jyoshnadr123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers who has allergic rhinitis are included in this trial |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilastine |
bilastine is a second-generation oral H1 antihistamine. It has emerged as a promising treatment option due to its high receptor selectivity, rapid onset of action, and lack of significant sedation or cardiotoxicity. Unlike many antihistamines bilastine demonstrates limited penetration of the blood-brain barrier, reducing its central nervous system effects. Furthermore it requires no dosage adjustments in those with renal or hepatic impairment |
| Comparator Agent |
Levocetirizine |
H1 antihistamine used in allergic rhinitis. with somnelence being most common side effect. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children between 6-18 years of age group with AR
And
Having a minimum reflective total nasal symptom score of 3 on at least 4 days in the previous 7 days
|
|
| ExclusionCriteria |
| Details |
Children with known hypersensitivity to any of the study drugs
Children who have received any of the following drugs in the preceding 7 days that is oral or intranasal corticosteroids oral or intranasal antihistamines or leukotriene receptor antagonists like montelukast
Children with history of upper respiratory tract infection in the previous 7 days
Children with any of the following disorders
structural diseases of the nose or chronic sinusitis or chronic liver disease or chronic kidney disease or intellectual disability or congenital or acquired heart disease or diabetes or malignancies or primary or secondary immunodeficiency or coagulation disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measuring the change in allergic symptoms as assessed by the total reflective total nasal symptom score |
2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The individual rTNSS scores
The overall scores on the MiniRQLQ
Adverse effects of the study drugs
Adherence to the protocol
|
2weeks |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
16/04/2025 |
| 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 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
|
This study is randomised controled trial comparing effectiveness of bilastine versus levocetirizine in children with allergic rhinitis.This study is being done in aiims pediatric department, using the score rtnss children of age 6-18years are being included into the study randomly and they are supplemented with bilastine or levocetirizine and will be asessed after 2weeks with rtnss scores comparing with the baseline scores.overall duration of study is estimated to be 18months. |