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

January 3, 2025 updated by: Innowage Limited

Evaluation of Breathe-Easy Hayfever Care for Managing Symptoms in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Gyansanjeevani India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hayfever Care
Hayfever Care, a powdered natural food supplement.
Dietary supplement: Hayfever Care

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
Other: Wait-list Care
No supplement was given during the trial period
Other: Wait-list Control
Personalized Diet and Lifestyle Advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Well-being Numerical Rating Scales
Time Frame: Change from Baseline to 4 weeks after baseline
Change from Baseline to 4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Symptom Dry Eyes
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Itching Eyes
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Burning Eyes
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Respiratory Complaints
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Sneezing
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Rhinitis
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Fatigue
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.
Change of Symptom Headache
Time Frame: Change in symptom scores from baseline to 4 weeks.
Change in symptom scores from baseline to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innowage Limited

Collaborators

Mettle Networks

Investigators

  • Study Chair: Sandeep Shinde, Mettle Networks
  • Study Director: Dr. Pradyuman S Rathore, Innowage, India
  • Principal Investigator: Dr Mridu Sharma, Gyansanjeevani India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

June 6, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InnUK/MN/0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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