Breathe-Easy: Hayfever Care for Patients With Seasonal Allergic Rhinitis

Not Applicable

Completed

• Conditions: Hayfever; Allergy Pollen; Allergic Rhinitis

• Registration Number: NCT06765239
• Lead Sponsor: Innowage Limited

Brief Summary

This waitlist-controlled trial aims to evaluate the therapeutic effectiveness of Hayfever Care by assessing disease-specific symptoms over a 4-week period. Additionally, the study examines the tolerability and safety of the solution.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-24
• Primary Completion: 2024-06-06
• Study Completion: 2024-06-15
• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Mild to moderate symptoms during the hayfever season
• Generally healthy individuals without chronic illnesses
• Willingness to comply with study requirements, including completing symptom diaries.

Exclusion Criteria

• History of anaphylaxis or severe hayfever symptoms requiring emergency treatment.
• Pregnant or breastfeeding
• History of substance abuse or excessive alcohol consumption.
• Use of systemic corticosteroids, immunotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Well-being Numerical Rating Scales	Change from Baseline to 4 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
Change of Symptom Dry Eyes	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Itching Eyes	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Burning Eyes	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Respiratory Complaints	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Sneezing	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Rhinitis	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Fatigue	Change in symptom scores from baseline to 4 weeks.
Change of Symptom Headache	Change in symptom scores from baseline to 4 weeks.

Trial Locations

Locations (1)

Gyansanjeevani India; 🇮🇳 Jaipur, Rajasthan, India