HayfeverNCT06765239
Breathe-Easy: Hayfever Care for Patients With Seasonal Allergic Rhinitis
A study testing Hayfever Care in people with Hayfever and Allergy Pollen, run by Innowage Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hayfever, Allergy Pollen, Allergic Rhinitis
- What is being tested?
- Hayfever Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndia
- Study dates
- 24 Apr 2024to 15 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate symptoms during the hayfever season
- Generally healthy individuals without chronic illnesses
- Willingness to comply with study requirements, including completing symptom diaries.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hayfever, Allergy Pollen, Allergic Rhinitis
- Being tested
- Hayfever Care, Wait-list Control
- Keywords
- Breathe-Easy, Hayfever Care
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hayfever CareDietary supplement
Also called Mettle's Hayfever Care
Powdered natural food supplement provided as a decoction, to be taken twice daily.
Personalized Diet and Nutrition Guidance along with Lifestyle Advice
Wait-list ControlOther
Personalized Diet and Lifestyle Advice
| Study group | Role | What they receive |
|---|---|---|
| Hayfever Care | Experimental | Hayfever Care, a powdered natural food supplement. Receives: Dietary Supplement: Hayfever Care |
| Wait-list Care | Other | No supplement was given during the trial period Receives: Other: Wait-list Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being Numerical Rating Scales
Measured: Change from Baseline to 4 weeks after baseline
Secondary outcomes (8)
Change of Symptom Dry Eyes
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Itching Eyes
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Burning Eyes
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Respiratory Complaints
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Sneezing
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Rhinitis
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Fatigue
Measured: Change in symptom scores from baseline to 4 weeks.
Change of Symptom Headache
Measured: Change in symptom scores from baseline to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start24 Apr 2024
- Primary completion6 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HayfeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innowage Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mettle Networks
- Responsible party
- Sponsor
- Investigators
- Sandeep Shinde, Study chair, Mettle NetworksDr. Pradyuman S Rathore, Study director, Innowage, IndiaDr Mridu Sharma, Principal investigator, Gyansanjeevani India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765239
- Sponsor's protocol ID
- InnUK/MN/0120
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided