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

An open label randomized comparative clinical trial on Efficacy and Safety of Bilastine tablet, Fluticasone and Mometasone nasal spray in allergic rhinitis; A tertiary care hospital based prospective interventional study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058841

Enrollment

240

Registered

2023-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified Health Condition 2: D898- Other specified disorders involving the immune mechanism, not elsewhere classified

Interventions

Intervention1: Bilastine tablet 20mg HS for 6weeks: Bilastine tablet 20mg at bedtime for 6 weeks Control Intervention1: 3 parallel arm: Patients satisfying the eligibility criteria will be randomised

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1.To compare Efficacy and Safety of Bilastine Tablet, Fluticasone and Mometasone Nasal Spray by applying SNOTT-22 scores in allergic rhinitis. 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

Measure	Time frame
To compare the compliance to medication and causes of non compliance among Bilastine tablet, Fluticasone and Mometasone nasal spray.Timepoint: 6 weeks	—

Countries

India

Contacts

Public ContactRohit Chauhan

Indira Gandhi Medical College Shimla

Dr.anamika.thakur@gmail.com9418477500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026