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

NCT ID: NCT06765239

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Hayfever Allergy Pollen Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hayfever Care

Hayfever Care, a powdered natural food supplement.

Group Type EXPERIMENTAL

Hayfever Care

Intervention Type DIETARY_SUPPLEMENT

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

Personalized Diet and Nutrition Guidance along with Lifestyle Advice

Wait-list Care

No supplement was given during the trial period

Group Type OTHER

Wait-list Control

Intervention Type OTHER

Personalized Diet and Lifestyle Advice

Interventions

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Hayfever Care

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

Personalized Diet and Nutrition Guidance along with Lifestyle Advice

Intervention Type DIETARY_SUPPLEMENT

Wait-list Control

Personalized Diet and Lifestyle Advice

Intervention Type OTHER

Other Intervention Names

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Mettle's Hayfever Care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mettle Networks

UNKNOWN

Sponsor Role collaborator

Innowage Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandeep Shinde

Role: STUDY_CHAIR

Mettle Networks

Dr. Pradyuman S Rathore

Role: STUDY_DIRECTOR

Innowage, India

Dr Mridu Sharma

Role: PRINCIPAL_INVESTIGATOR

Gyansanjeevani India

Locations

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Gyansanjeevani India

Jaipur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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InnUK/MN/0120

Identifier Type: -

Identifier Source: org_study_id

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