| CTRI Number |
CTRI/2025/02/080336 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
this study is basically to see serum arginase level and total nasal score pre and post treatment with tablet montelukast and tablet levocetrizine and see improvement in allergic rhinitis patients |
|
Scientific Title of Study
|
Evaluation of the Effect of Montelukast Sodium and Levocetrizine on Serum
Arginase Levels in Patients with Allergic Rhinitis in a Tertiary Care Center- A
Randomized Controlled 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 |
Vignesh S |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District
Chennai
TAMIL NADU
603203
India |
| Phone |
9442149281 |
| Fax |
|
| Email |
drvignesh45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin M Nagarkar |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District
Chennai
TAMIL NADU
603203
India |
| Phone |
9940036038 |
| Fax |
|
| Email |
dean.medical.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh S |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District
Chennai
TAMIL NADU
603203
India |
| Phone |
9442149281 |
| Fax |
|
| Email |
drvignesh45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District |
|
|
Primary Sponsor
|
| Name |
Vignesh S |
| Address |
Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District |
| 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 |
| Vignesh S |
SRM medical college |
Department of ENT, C Block, Room no 116, SRM medical college, S.R.M Nagar , Potheri, Kattankulathur,Chengalpattu District- 603203
Chennai
TAMIL NADU |
9442149281
drvignesh45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Levocetrizine 10 mg 0-0-1 |
Levocetrizine 10 mg 0-0-1 X 4 weeks |
| Intervention |
Montelukast sodium 10 mg |
Montelukast Sodium 10mg 0-0-1 x 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Allergic rhinitis |
|
| ExclusionCriteria |
| Details |
Asthma
Polyposis
Systemic disease like eosinophilia
Pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate serum arginase levels in allergic rhinitis patient |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate total nasal scores |
4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/02/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - PUBMED
- For how long will this data be available start date provided 06-02-2025 and end date provided 09-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
TO EVALUATE THE EFFECT OF LEVOCETRIZINE AND MONTELUKAST SODIUM ON SERUM ARGINASE LEVEL AND TOTAL NASAL SCORE PRE AND POST DRUG ADMINISTRATON BY ELISA METHOD |