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Clinical Trials/NCT06765239
NCT06765239CompletedNot Applicable

Evaluation of Breathe-Easy Hayfever Care for Managing Symptoms in Patients With Seasonal Allergic Rhinitis

Innowage Limited1 site in 1 country63 target enrollmentStarted: April 24, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
63
Locations
1
Primary Endpoint
Well-being Numerical Rating Scales
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hayfever Care

Experimental

Hayfever Care, a powdered natural food supplement.

Intervention: Hayfever Care (Dietary Supplement)

Wait-list Care

Other

No supplement was given during the trial period

Intervention: Wait-list Control (Other)

Outcomes

Primary Outcomes

Well-being Numerical Rating Scales

Time Frame: Change from Baseline to 4 weeks after baseline

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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