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OpenTrials
Completed

NCT Number: NCT06765239

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

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.

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Key information

Conditions

Hayfever Allergic Rhinitis Allergy Pollen Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gyansanjeevani India

Jaipur, Rajasthan, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hayfever Care

Dietary Supplement

Powdered natural food supplement provided as a decoction, to be taken twice daily.

Personalized Diet and Nutrition Guidance along with Lifestyle Advice

Other names: Mettle's Hayfever Care

Wait-list control

Other

Personalized Diet and Lifestyle Advice

Primary outcomes

  1. Well-being Numerical Rating Scales

    Time frame: Change from Baseline to 4 weeks after baseline

Secondary outcomes

  1. Change of Symptom Dry Eyes

    Time frame: Change in symptom scores from baseline to 4 weeks.

  2. Change of Symptom Itching Eyes

    Time frame: Change in symptom scores from baseline to 4 weeks.

  3. Change of Symptom Burning Eyes

    Time frame: Change in symptom scores from baseline to 4 weeks.

  4. Change of Symptom Respiratory Complaints

    Time frame: Change in symptom scores from baseline to 4 weeks.

  5. Change of Symptom Sneezing

    Time frame: Change in symptom scores from baseline to 4 weeks.

  6. Change of Symptom Rhinitis

    Time frame: Change in symptom scores from baseline to 4 weeks.

  7. Change of Symptom Fatigue

    Time frame: Change in symptom scores from baseline to 4 weeks.

  8. Change of Symptom Headache

    Time frame: Change in symptom scores from baseline to 4 weeks.

Sponsors and collaborators

Lead sponsor

Innowage Limited

Industry

Collaborators

  • Mettle Networks

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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