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A clinical trial to study the effect of Bilastine tablet, Fluticasone and Mometasone nasal spray in allergic rhinitis.

Phase 4
Conditions
Health Condition 1: J309- Allergic rhinitis, unspecifiedHealth Condition 2: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
Registration Number
CTRI/2023/10/058841
Lead Sponsor
INDIRA GANDHI MEDICAL COLLEGE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.All allergic rhinitis diagnosed patients attending ENT OPD irrespective of type of allergic rhinitis.

2.Patients aged 18-50 years of either sex will be enrolled for the study.

3.Written informed Consent.

4.Adequate literacy to complete the dairy card.

Exclusion Criteria

1.Patients with acute or chronic sinusitis, chronic purulent postnasal drip, rhinitis sicca, atrophic rhinitis, rhinitis medicamentosa. nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps, marked septal deviations, or recent nasal surgery that would have significantly interfered with nasal air flow.

2.Hypersensitivity to Bilastine, Fluticasone, Mometasone and/or any other drug of same class.

3.Patients with an active pulmonary disorder including asthma, upper respiratory tract or sinus infection that required antibiotic therapy within 14 days of the screening visit or an upper respiratory trat infection/ocular infection within 7 days of screening visit.

4.Patients with the history of narrow-angle glaucoma, increased intraocular pressure, and posterior sub capsular cataract.

5.Patients with RBS of >140mg/dl, serum transminases of twice upper normal limit, serum bilirubin of >2.0mg/dl, and/or serum creatnine >2.5mg/dl.

6.Pregnant or lactating females.

7.Pateints who had received the following medications in the given time frame; nasal/oral decongestants, nasal/antihistamines; 72 hours; nasal/inhaled corticosteriods, leukotriene receptor antagonists, 5-lipooxygenase inhibitors, methylxanthines, nonprescription drugs; 7days; MOA inhibitors: 14 days; oral corticosteroids ;12 weeks.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To compare Efficacy and Safety of Bilastine Tablet, Fluticasone and Mometasone Nasal Spray by applying SNOTT-22 scores in allergic rhinitis. <br/ ><br>2.To comapare the Safety of Bilastine tablet, Fluticasone and Mometasone nasal spray using AE and ADR in adult patients of allergic rhinitis.Timepoint: 6 weeks
Secondary Outcome Measures
NameTimeMethod
To compare the compliance to medication and causes of non compliance among Bilastine tablet, Fluticasone and Mometasone nasal spray.Timepoint: 6 weeks
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