Breathe-Easy: Hayfever Care for Patients With Seasonal Allergic Rhinitis
Evaluation of Breathe-Easy Hayfever Care for Managing Symptoms in Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedFirst Submitted
Initial submission to the registry
January 3, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2025
CompletedJanuary 9, 2025
January 1, 2025
1 month
January 3, 2025
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Well-being Numerical Rating Scales
Change from Baseline to 4 weeks after baseline
Secondary Outcomes (8)
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.
- +3 more secondary outcomes
Study Arms (2)
Hayfever Care
EXPERIMENTALHayfever Care, a powdered natural food supplement.
Wait-list Care
OTHERNo supplement was given during the trial period
Interventions
Powdered natural food supplement provided as a decoction, to be taken twice daily. Personalized Diet and Nutrition Guidance along with Lifestyle Advice
Eligibility Criteria
You may qualify if:
- Mild to moderate symptoms during the hayfever season
- Generally healthy individuals without chronic illnesses
- Willingness to comply with study requirements, including completing symptom diaries.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Innowage Limitedlead
- Mettle Networkscollaborator
Study Sites (1)
Gyansanjeevani India
Jaipur, Rajasthan, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sandeep Shinde
Mettle Networks
- STUDY DIRECTOR
Dr. Pradyuman S Rathore
Innowage, India
- PRINCIPAL INVESTIGATOR
Dr Mridu Sharma
Gyansanjeevani India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2025
First Posted
January 9, 2025
Study Start
April 24, 2024
Primary Completion
June 6, 2024
Study Completion
June 15, 2024
Last Updated
January 9, 2025
Record last verified: 2025-01