CClinicalTrials.gg
Sign In
CompletedNCT06765239Updated Jan 9, 2025

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

An interventional study of Hayfever Care and Wait-list Control in Hayfever, Allergy Pollen and Allergic Rhinitis, sponsored by Innowage Limited. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Innowage Limited · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hayfever
  • Allergy Pollen
  • Allergic Rhinitis

Keywords

  • Breathe-Easy
  • Hayfever Care
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 63 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Innowage Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Hayfever Care

    Hayfever Care, a powdered natural food supplement.

    Dietary Supplement: Hayfever Care

  • Other
    Wait-list Care

    No supplement was given during the trial period

    Other: Wait-list Control

Interventions

  • Dietary supplementHayfever Care

    Powdered natural food supplement provided as a decoction, to be taken twice daily. Personalized Diet and Nutrition Guidance along with Lifestyle Advice

    Also known as: Mettle's Hayfever Care

  • OtherWait-list Control

    Personalized Diet and Lifestyle Advice

06

What researchers measure

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.

07

Study locations

1 site
  • Gyansanjeevani India
    Jaipur, Rajasthan, India
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06765239
Lead sponsor
Innowage Limited
Collaborators
Mettle Networks
Responsible party
Sponsor
First posted
Jan 9, 2025
Start date
Apr 24, 2024
Primary completion
Jun 6, 2024
Completion
Jun 15, 2024
Last update
Jan 9, 2025

Study contacts

Sandeep Shinde
study chair · Mettle Networks
Dr. Pradyuman S Rathore
study director · Innowage, India
Dr Mridu Sharma
principal investigator · Gyansanjeevani India

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis→

Other studies from this sponsor

Innowage Limited

Start the discussion