| CTRI Number |
CTRI/2024/11/076733 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares how safe and effective two medicines namely Rupatadine and Fexofenadine are, when taken by mouth to treat allergy. |
|
Scientific Title of Study
|
A comparative study on safety and efficacy of oral fexofenadine and oral rupatadine among patients 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 |
Dr Kriti Jalota |
| Designation |
Professor |
| Affiliation |
Rama Medical college,kanpur |
| Address |
Department of Pharmacology and Therapeutics,Rama medical college,Mandhana Kanpur,Uttar Pradesh,India 209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9450162472 |
| Fax |
|
| Email |
drkritijalota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kriti Jalota |
| Designation |
Professor |
| Affiliation |
Rama Medical college,kanpur |
| Address |
Department of Pharmacology and Therapeutics,Rama medical college,Mandhana Kanpur,Uttar Pradesh,India 209217
UTTAR PRADESH
209217
India |
| Phone |
9450162472 |
| Fax |
|
| Email |
drkritijalota@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Khatoon |
| Designation |
Junior Resident |
| Affiliation |
Rama Medical college,kanpur |
| Address |
Department of Pharmacology and Therapeutics,Rama medical college,Mandhana Kanpur,Uttar Pradesh,India 209217
132/325 Babupurwa T.P. Nagar near nai Masjid-208023
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
7860753786 |
| Fax |
|
| Email |
kzainab03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology and Department of Otorhinolaryngology
Infrastructural support by Rama medical college hospital and research centre, madhana Kanpur,uttar pradesh, India-09217 |
|
|
Primary Sponsor
|
| Name |
Rama medical College Hospital and Research CentreKanpur |
| Address |
Department of Pharmacology and Therapeutics,Room number-03154,second floor, medical college building,Mandhana,Kanpur ,Uttar Pradesh,India-209217 |
| 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 |
| Dr Kriti Jalota |
Rama medical college and hospital |
Department of pharmacology room number-02154 and Department of Otorhinolaryngology room number-1,
Rama medical College Hospital and Research Centre,Mandhana Kanpur,Uttar Pradesh,India -209217
Kanpur Nagar
UTTAR PRADESH |
9450162472
drkritijalota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Rama medical College Hospital and Research Centre,Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antihistaminic - fexofenadine |
tab Fexofenadine 180mg once daily x 7 days for each patient |
| Intervention |
Antihistaminic- rupatadine |
tab Rupatadine 10 mg once daily x7 days for each patient enrolled |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of both the sexes in ages 16-60 years of age
2.having one or more features of allergic rhinitis such as sneezing, watery nasal discharge, itching in the nose/throat and nasal blockade.
3.Willing to give Informed & written consent.
4.SNOT score-22 with mild and moderate category |
|
| ExclusionCriteria |
| Details |
active disease like TB infection
Pregnant and lactating women or willing to conceive
with known history of hypersensitivity.
Patient above age 60 years lean and thin
Any chronic diseases like CKD Hepatic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and Efficacy of rupatadine and fexofenadine after seven days of treatment |
Baseline(Day 0),Day 7,Day14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline(day 0),Day 7,Day 14 |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
23/11/2024 |
| 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 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
|
STUDY OF COMPARISON ON SAFETY AND EFFICACY OF FEXOFENADINE AND RUPATADINE AMONG PATIENTS WITH ALLERGIC RHINITIS.
Allergic Rhinitis is defined as having two or more symptoms of rhinorrhea, sneezing, nasal obstruction, anosmia/hyposmia and itching of nose during two or more consecutive days for more than 1 hour on most days. Allergic rhinitis is a common disease affecting0.8 to 39.7% of the world population.
A clinical history of rhinitis symptoms occurring in a temporal relationship to allergen exposure and documentation of sensitization to an environmental allergen are required for a diagnosis of allergic rhinitis. Although commonly seasonal due to elicitation by airborne pollens, it can be perennial in an environment of chronic exposure to house dust mites, animal danders, or insect (cockroach) products.Allergic Rhinitis is a common disease affecting 0.8 to 39.7 percent of the world depending on location.
OBJECTIVES
- To monitor the adverse drug reactions for safety profile of the drugs.
- To evaluate the Efficacy and cost effectiveness of the treatment groups.
- Venue of Study: Department of Pharmacology with collaboration of Department of Oto-Rhino-Laryngology at Rama medical college and hospital and research centre, Kanpur.
- Type of study: The study will be comparative, observational, randomized, parallel group study.
- Duration of the study: Research study will be for 18 months.
- Sample size:142 patients of allergic rhinitis.
- Methodology: Patients with symptoms of allergic rhinitis visiting ENT OPD fulfilling inclusion criteria and exclusion criteria are taken in the study.
An appropriate number of patients (150) will be enrolled and will be divided into two groups via randomised method.
Group I will be administered drug Fexofenadine180mg OD for 7 days
Group II with drug Rupatadine 10mg OD for 7 days.
Patients who would lost to follow up or patient who would be not relieved after 7 days of drug therapy will be started with nasal corticosteroid and will be excluded from the study. |